The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for The Pilot Audiometer.
| Device ID | K951527 |
| 510k Number | K951527 |
| Device Name: | THE PILOT AUDIOMETER |
| Classification | Audiometer |
| Applicant | AMERICAN ELECTROMEDICS CORP. 13 COLUMBUS DR. SUITE 18 Amherst, NH 03031 |
| Contact | Noel A Wren |
| Correspondent | Noel A Wren AMERICAN ELECTROMEDICS CORP. 13 COLUMBUS DR. SUITE 18 Amherst, NH 03031 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THE PILOT AUDIOMETER 76461032 2819048 Dead/Cancelled |
Bernafon Inc. 2002-10-24 |
![]() THE PILOT AUDIOMETER 76461028 2820839 Live/Registered |
Diagnostic Group, LLC 2002-10-24 |
![]() THE PILOT AUDIOMETER 74539404 1947645 Dead/Cancelled |
AMERICAN ELECTROMEDICS CORPORATION 1994-06-17 |