Data / Medical devices / United Kingdom / G.M. Instruments Ltd.
G.M. Instruments Ltd.: FDA-registered device maker in Irvine North Ayrshire, United Kingdom, 2 510(k) clearances
G.M. Instruments Ltd. is registered with the FDA (registration 8040391) in Irvine North Ayrshire, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 30, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8040391
- FEI number
- 5902
- Address
- Greig House, Block 1 Annickbank Innovation Campus Annick Road, Irvine North Ayrshire, United Kingdom, KA11 4LF
- Owner or operator
- G.M. INSTRUMENTS LTD. (8040391)
- Roles
- Manufacturer
- First device listed
- March 14, 1985
- Registered through
- 2026
- Brand names listed
- GM Instruments A1 Acoustic Rhinometer, GM Instruments NR6 Rhinomanometer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Rhinoanemometer (Measurement Of Nasal Decongestion) | BXQ | 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 |
|---|---|---|---|---|---|---|
| September 30, 1998 | K972140 | A1 ACOUSTIC RHINOMETER | BXQ | Substantially Equivalent | G.M. Instruments , Ltd. | accessdata.fda.gov |
| August 6, 1990 | K902120 | MERCURY RHINOMANOMETER | BXQ | Substantially Equivalent | Life-Tech Intl., Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 30, 1998. 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.