The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for Ae1162 Clinical/diagnostic Audiometer.
| Device ID | K881760 |
| 510k Number | K881760 |
| Device Name: | AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER |
| Classification | Audiometer |
| 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 | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-25 |
| Decision Date | 1988-06-10 |