The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for Middle Ear Analyzer, Model Ae-803.
| Device ID | K905213 |
| 510k Number | K905213 |
| Device Name: | MIDDLE EAR ANALYZER, MODEL AE-803 |
| Classification | Tester, Auditory Impedance |
| Applicant | AMERICAN ELECTROMEDICS CORP. 13 SAGAMORE PARK RD. Hudson, NH 03051 |
| Contact | Thomas M Gleason |
| Correspondent | Thomas M Gleason AMERICAN ELECTROMEDICS CORP. 13 SAGAMORE PARK RD. Hudson, NH 03051 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-02-20 |