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 |