The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Tracor Model Ra600 Microprocessor Audiometer.
| Device ID | K853245 |
| 510k Number | K853245 |
| Device Name: | TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER |
| 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 | 1985-08-01 |
| Decision Date | 1985-10-16 |