Data / Medical devices / United States / Diagnostic Group LLC
Diagnostic Group LLC: FDA-registered device maker in Eden Prairie, MN, United States, 28 510(k) clearances
Diagnostic Group LLC is registered with the FDA (registration 2113281) in Eden Prairie, MN, United States. It lists 7 device types. The FDA files 28 510(k) clearances under its listings, the newest dated April 24, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2113281
- Address
- 10395 W 70th St, Eden Prairie, MN, United States, 55344
- Owner or operator
- DEMANT A/S (8010048)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 21, 1994
- Registered through
- 2026
- Brand names listed
- AC33, AC40, AD226, AD229, AD528, AD629, AM282, AS608 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Audiometer | EWO | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tester, Auditory Impedance | ETY | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tympanometer | NAS | 2 | Complaint file establishment | accessdata.fda.gov |
| Tympanometer, Exempt | PTP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2020 | K193033 | GSI Audera Pro | GWJ | Substantially Equivalent | Grason Stadler | accessdata.fda.gov |
| May 11, 2018 | K180287 | GSI Corti | EWO | Substantially Equivalent | Grason-Stadler, Inc. | accessdata.fda.gov |
| February 14, 2018 | K173567 | Sera | EWO | Substantially Equivalent | Interacoustics A/S | accessdata.fda.gov |
| October 20, 2017 | K172403 | GSI Novus | EWO | Substantially Equivalent | Grason-Stadler, Inc. | accessdata.fda.gov |
| July 28, 2017 | K171265 | Otowave 302 Portable Tympanometer | NAS | Substantially Equivalent | Amplivox, Ltd. | accessdata.fda.gov |
| July 15, 2015 | K151616 | AT235 | ETY | Substantially Equivalent | Interacoustics A/S | accessdata.fda.gov |
| June 25, 2015 | K151509 | GSI TympStar Pro Middle Ear Analyzer | ETY | Substantially Equivalent | Diagnostic Group, Dba Grason-Stadler | accessdata.fda.gov |
| April 23, 2015 | K150163 | Otowave 202 Portable Tympanometer | NAS | Substantially Equivalent | Amplivox, Ltd. | accessdata.fda.gov |
| March 26, 2015 | K150491 | ER36 Series OAE Test System | EWO | Substantially Equivalent | Etymotic Research, Inc. | accessdata.fda.gov |
| December 16, 2011 | K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | EWO | Substantially Equivalent | Etymotic Research, Inc. | accessdata.fda.gov |
| April 9, 2009 | K083861 | TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE | ETY | Substantially Equivalent | Interacoustics AS | accessdata.fda.gov |
| January 29, 2009 | K082035 | MAICO MB 11 WITH BERAPHONE PROBE | GWJ | Substantially Equivalent | Maico Diagnostics | accessdata.fda.gov |
| July 16, 2008 | K081841 | AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER | ETY | Substantially Equivalent | Amplivox, Ltd. | accessdata.fda.gov |
| June 23, 2006 | K060883 | PILOT TEST OR DETECTIVE AUDIOMETERS | EWO | Substantially Equivalent | Interacoustics A/S | accessdata.fda.gov |
| June 5, 2006 | K060885 | MODEL MI 44 TYMPANOMETER | EWO | Substantially Equivalent | Maico-Diagnostics | accessdata.fda.gov |
| March 7, 2003 | K024205 | AUDIOSCREENER OAE+ABR | EWO | Substantially Equivalent | Everest Biomedical Instruments Co. | accessdata.fda.gov |
| August 24, 2001 | K011746 | MB 11 | GWJ | Substantially Equivalent | Maico Diagnostic GmbH | accessdata.fda.gov |
| July 26, 2001 | K011135 | GSI AUDERA | EWO | Substantially Equivalent | Nicolet Biomedical | accessdata.fda.gov |
| April 12, 2000 | K000097 | GSI 2000 MIDDLE EAR ANALYZER | ETY | Substantially Equivalent | Grason-Stadler, Inc. | accessdata.fda.gov |
| November 18, 1998 | K983051 | AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | ETY | Substantially Equivalent | American Electromedics Corp. | accessdata.fda.gov |
| November 18, 1998 | K983049 | AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER | ETY | Substantially Equivalent | American Electromedics Corp. | accessdata.fda.gov |
| November 17, 1998 | K983048 | AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER | EWO | Substantially Equivalent | American Electromedics Corp. | accessdata.fda.gov |
| November 17, 1998 | K983046 | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER | ETY | Substantially Equivalent | American Electromedics Corp. | accessdata.fda.gov |
| February 10, 1998 | K974237 | GSI 70 AUDIOPATH SCREENER | EWO | Substantially Equivalent | Grason-Stadler, Inc. | accessdata.fda.gov |
| July 24, 1995 | K953161 | MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION | ETY | Substantially Equivalent | Maico Hearing Instruments, Inc. | accessdata.fda.gov |
| February 2, 1993 | K925585 | GSI 38 AUTO TYMP | ETY | Substantially Equivalent | Lucas Grason-Stadler, Inc. | accessdata.fda.gov |
| April 30, 1991 | K905704 | MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER | ETY | Substantially Equivalent | Maico Hearing Instruments, Inc. | accessdata.fda.gov |
| November 24, 1987 | K873298 | ELEC-TIP | GXY | Substantially Equivalent | Etymotic Research | accessdata.fda.gov |
Compare with other makers
- All makers of Audiometer
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Spirometer, Diagnostic
- All makers of Tester, Auditory Impedance
- All makers of Tympanometer, Exempt
Updated April 24, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.