510(k) K822414
K822414 is an FDA 510(k) premarket notification submitted by Tracor Instruments, Inc. for the device "TRACOR RA400 AUDIOMETER". The FDA issued a decision of Substantially Equivalent on August 30, 1982. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Tracor Instruments, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 1982
- Date Received
- August 11, 1982
- 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