Data / Medical devices / United States / Consolidated Research, Inc.
Consolidated Research, Inc.: FDA-registered device maker in Euclid, OH, United States, 3 510(k) clearances
Consolidated Research, Inc. is registered with the FDA (registration 3009770872) in Euclid, OH, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 19, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009770872
- Address
- 26250 Euclid Ave Ste 709, Euclid, OH, United States, 44132
- Owner or operator
- Consolidated Research, Inc. (10041808)
- Roles
- Manufacturer
- First device listed
- September 5, 2012
- Registered through
- 2026
- Brand names listed
- Zmachine DT-100, Zmachine DT-200, Zmachine DT-300, Zmachine Insight, Zmachine Insight+, Zmachine Synergy
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 2 | Manufacturer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | Manufacturer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 19, 2017 | K172986 | Zmachine Synergy | OLV | Substantially Equivalent | Consolidated Research of Richmond, Inc. Dba General Sleep CO | accessdata.fda.gov |
| January 20, 2015 | K142825 | Zmachine | OLZ | Substantially Equivalent | Consolidated Research of Richmond, Inc. | accessdata.fda.gov |
| March 31, 2011 | K101830 | ZMACHINE, MODEL DT-100 | OLV | Substantially Equivalent | Consolidated Research of Richmond, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- All makers of Ventilatory Effort Recorder
Updated December 19, 2017. 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.