The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Tracor Ra 410 Audiometer.
Device ID | K780450 |
510k Number | K780450 |
Device Name: | TRACOR RA 410 AUDIOMETER |
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 | 1978-03-20 |
Decision Date | 1978-03-30 |