510(k) K955442
K955442 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "KOWA SC-1200 PHOTO SLIT LAMP SYSTEM". The FDA issued a decision of Substantially Equivalent on January 3, 1996. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Kowa Optimed, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1996
- Date Received
- November 28, 1995
- 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