510(k) K123208
K123208 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 March 19, 2013. 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
- March 19, 2013
- Date Received
- October 12, 2012
- 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