510(k) K021787
- Device
- VISUCAM
- Applicant
- CARL ZEISS OPHTHALMIC SYSTEMS, INC.
- 510(k) number
- K021787
- Product code
- NFF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-21
- Date received
- 2002-05-30
- Regulation
- 892.2010
- Classification name
- Device, Storage, Images, Ophthalmic
- Medical specialty
- Radiology
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIONNE N LABATORE
- Address
- 555 Thireenth St., NW Washington DC US 20004 20004
FDA Registration Numbers#
- 1000176188
- 3008252121
- 3002807715
- 3038356864
- 3010300699
- 3009990264
- 1054713
- 3013403214
- 9615030
- 8030392
- 3014232530
- 2936921
Source Documents#
Legacy Summary#
summary
FDA Review#
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