510(k) K812764
K812764 is an FDA 510(k) premarket notification submitted by Koi, Inc. for the device "KOI BLUE FIELD ENTOPTOSCOPE". The FDA issued a decision of Substantially Equivalent on December 2, 1981. The device falls under product code HKL (Retinoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1780. Koi, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1981
- Date Received
- October 2, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retinoscope, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1780
- Review Panel
- OP
- Submission Type