The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for Auto Impedance Meter Ae105 & Ae106 W/audiometer.
| Device ID | K883728 |
| 510k Number | K883728 |
| Device Name: | AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER |
| Classification | Tester, Auditory Impedance |
| Applicant | AMERICAN ELECTROMEDICS CORP. 13 SAGAMORE PARK RD. Hudson, NH 03051 |
| Contact | T. M Gleason |
| Correspondent | T. 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 | 1988-08-31 |
| Decision Date | 1989-01-03 |