510(k) K822817
K822817 is an FDA 510(k) premarket notification submitted by Fidelty Hearing Instruments, Inc. for the device "DOCE ALL-IN-THE-EAR AID". The FDA issued a decision of Substantially Equivalent on January 18, 1983. The device falls under product code FSD (Binder, Abdominal), a Class I device regulated under 21 CFR 880.5160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1983
- Date Received
- September 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Binder, Abdominal
- Device Class
- Class I
- Regulation Number
- 880.5160
- Review Panel
- HO
- Submission Type