Data / Medical devices / Canada / Amico Diagnostic Incorporated
Amico Diagnostic Incorporated: FDA-registered device maker in Richmond Hill Ontario, Canada, 4 510(k) clearances
Amico Diagnostic Incorporated is registered with the FDA (registration 3009685433) in Richmond Hill Ontario, Canada. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 26, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009685433
- Address
- 122 East Beaver Creek Road, Richmond Hill Ontario, Canada, L4B 1G6
- Owner or operator
- Amico Diagnostic Incorporated (10040947)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- June 5, 2012
- Registered through
- 2026
- Brand names listed
- BLOOD PRESSURE CUFFS & DEVICES, ELECTRONIC THERMOMETER, INFRARED TYMPANIC ELECTRONIC THERMOMETER, MANUAL STETHOSCOPE - STHETHOSCOPES MULTIPLE & ACCESSORIES, OPHTHALMOSCOPES - AC-POWERED, OPHTHALMOSCOPES MULTIPLE & ACCESSORIES, OTOSCOPE AC/DC POWERED
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Ophthalmoscope, Ac-Powered | HLI | 2 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 26, 2014 | K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES | HLI | Substantially Equivalent | Amico Diagnostic Incorporated | accessdata.fda.gov |
| May 22, 2006 | K060649 | GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 | FLL | Substantially Equivalent | Tyco Healthcare Group LP | accessdata.fda.gov |
| August 16, 2001 | K012444 | ABN ANEROID SPHYGMOMANOMETER | DXQ | Substantially Equivalent | Pt. Sugih Instrumendo Abadi | accessdata.fda.gov |
| January 11, 2001 | K003313 | FILAC FAS TEMP ELECTRONIC THERMOMETER | FLL | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
Compare with other makers
- All makers of Ophthalmoscope, Ac-Powered
- All makers of Blood Pressure Cuff
- All makers of Stethoscope, Manual
- All makers of Continuous Measurement Thermometer
- All makers of Otoscope
Updated March 26, 2014. 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.