510(k) K770888
K770888 is an FDA 510(k) premarket notification submitted by Medical Instrument Research Assoc., Inc. for the device "POMERANTZEFF EQUATOR PLUS CAMERA". The FDA issued a decision of Substantially Equivalent on June 3, 1977. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Medical Instrument Research Assoc., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1977
- Date Received
- May 16, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type