The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Tracor 200 Microprocessor Audiometer/tracor Ra 200.
Device ID | K851392 |
510k Number | K851392 |
Device Name: | TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 |
Classification | Audiometer |
Applicant | TRACOR INSTRUMENTS, INC. 6500 TRACOR LN. Austin, TX 78721 |
Contact | Jack C Foreman |
Correspondent | Jack C Foreman TRACOR INSTRUMENTS, INC. 6500 TRACOR LN. Austin, TX 78721 |
Product Code | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-09 |
Decision Date | 1985-06-20 |