510(k) K081797
K081797 is an FDA 510(k) premarket notification submitted by Konan Medical, Inc. for the device "IMAGE STORAGE SYSTEM, MODEL KSS-400". The FDA issued a decision of Substantially Equivalent on January 22, 2009. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Konan Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2009
- Date Received
- June 25, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Management, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- OP
- Submission Type