510(k) K093071
K093071 is an FDA 510(k) premarket notification submitted by Fundus Photo, LLC for the device "FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440". The FDA issued a decision of Substantially Equivalent on Nov 17, 2010. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 17, 2010
- Date Received
- Sep 30, 2009
- 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
- 510(k)