The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Speech Audiometer Ra 226.
Device ID | K780749 |
510k Number | K780749 |
Device Name: | SPEECH AUDIOMETER RA 226 |
Classification | Audiometer |
Applicant | TRACOR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-04 |
Decision Date | 1978-05-16 |