The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for American Electromedics Race Car Tympanometer W/integral Printer.
| Device ID | K983046 |
| 510k Number | K983046 |
| Device Name: | AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER |
| Classification | Tester, Auditory Impedance |
| Applicant | AMERICAN ELECTROMEDICS CORP. P.O. BOX 9169 Chico, CA 95927 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson AMERICAN ELECTROMEDICS CORP. P.O. BOX 9169 Chico, CA 95927 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-01 |
| Decision Date | 1998-11-17 |
| Summary: | summary |