The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for Clinical Tympanometer.
| Device ID | K833045 |
| 510k Number | K833045 |
| Device Name: | CLINICAL TYMPANOMETER |
| Classification | Tester, Auditory Impedance |
| Applicant | AMERICAN ELECTROMEDICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-06 |
| Decision Date | 1983-12-08 |