The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for Race Car Tympanometer.
| Device ID | K955289 |
| 510k Number | K955289 |
| Device Name: | RACE CAR TYMPANOMETER |
| Classification | Tester, Auditory Impedance |
| Applicant | AMERICAN ELECTROMEDICS CORP. 13 COLUMBUS DR. SUITE 18 Amherst, NH 03031 |
| Contact | Noel A Wren |
| Correspondent | Noel A Wren AMERICAN ELECTROMEDICS CORP. 13 COLUMBUS DR. SUITE 18 Amherst, NH 03031 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-16 |
| Decision Date | 1995-12-08 |