VISUCAM
FDA 510(k) clearance K021787 · decided 2002-06-21
Clearance details
- K-number
- K021787
- Device name
- VISUCAM
- Applicant
- Carl Zeiss Ophthalmic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-30
- Decision date
- 2002-06-21
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- NFF
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.