The following data is part of a premarket notification filed by G.m. Instruments Ltd. with the FDA for A1 Acoustic Rhinometer.
| Device ID | K972140 |
| 510k Number | K972140 |
| Device Name: | A1 ACOUSTIC RHINOMETER |
| Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
| Applicant | G.M. INSTRUMENTS LTD. UNIT 6, ASHGROVE ASHGROVE ROAD Kilwinning, GB Ka13 6pu |
| Contact | E. W Greig |
| Correspondent | E. W Greig G.M. INSTRUMENTS LTD. UNIT 6, ASHGROVE ASHGROVE ROAD Kilwinning, GB Ka13 6pu |
| Product Code | BXQ |
| CFR Regulation Number | 868.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-06 |
| Decision Date | 1998-09-30 |