510(k) K000368
K000368 is an FDA 510(k) premarket notification submitted by Clement Clarke Intl., Ltd. for the device "EYECAP IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 4, 2000. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Clement Clarke Intl., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2000
- Date Received
- Feb 4, 2000
- 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)