510(k) K102013
K102013 is an FDA 510(k) premarket notification submitted by Canon Inc. -Medical Equipment Group for the device "DIGITAL RETINAL CAMERA". The FDA issued a decision of Substantially Equivalent on October 29, 2010. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Canon Inc. -Medical Equipment Group has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2010
- Date Received
- July 16, 2010
- Clearance Type
- Special
- 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