510(k) K922570
K922570 is an FDA 510(k) premarket notification submitted by Resound Corp. for the device "RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1". The FDA issued a decision of Substantially Equivalent on August 6, 1992. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320. Resound Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1992
- Date Received
- June 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Group And Auditory Trainer
- Device Class
- Class II
- Regulation Number
- 874.3320
- Review Panel
- EN
- Submission Type