The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for Race Car Tympanometer With Audiometer(ae-rcaud I/quik Tymp 1(ae-quik 1)/quick Tymp 2(ae-quik 2).
| Device ID | K970279 |
| 510k Number | K970279 |
| Device Name: | RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) |
| Classification | Audiometer |
| 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 | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-03-18 |