510(k) K021787
K021787 is an FDA 510(k) premarket notification submitted by Carl Zeiss Ophthalmic Systems, Inc. for the device "VISUCAM". The FDA issued a decision of Substantially Equivalent on June 21, 2002. The device falls under product code NFF (Device, Storage, Images, Ophthalmic), a Class I device regulated under 21 CFR 892.2010. Carl Zeiss Ophthalmic Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2002
- Date Received
- May 30, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Storage, Images, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 892.2010
- Review Panel
- OP
- Submission Type