510(k) K853245
K853245 is an FDA 510(k) premarket notification submitted by Tracor Instruments, Inc. for the device "TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER". The FDA issued a decision of Substantially Equivalent on Oct 16, 1985. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Tracor Instruments, Inc. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 1985
- Date Received
- Aug 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type
- 510(k) Exempt