The following data is part of a premarket notification filed by Carl Zeiss Jena Gmbh with the FDA for Ff450 Plus Fundus Camera And Visupac Digital Image Archiving System, Or Ff450 Plus Visupac System.
| Device ID | K011877 |
| 510k Number | K011877 |
| Device Name: | FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CARL ZEISS JENA GMBH 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan CARL ZEISS JENA GMBH 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | HKI |
| Subsequent Product Code | NFF |
| Subsequent Product Code | NFG |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-15 |
| Decision Date | 2001-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471093032 | K011877 | 000 |