510(k) K132987
K132987 is an FDA 510(k) premarket notification submitted by C.S.O. S.R.L. for the device "COBRA FUNDUS CAMERA". The FDA issued a decision of Substantially Equivalent on July 3, 2014. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. C.S.O. S.R.L. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2014
- Date Received
- September 24, 2013
- 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