The following data is part of a premarket notification filed by Carl Zeiss Surgical Gmbh with the FDA for Zeiss Infrared 800 With Flow 800 Option.
| Device ID | K100468 |
| 510k Number | K100468 |
| Device Name: | ZEISS INFRARED 800 WITH FLOW 800 OPTION |
| Classification | System, X-ray, Angiographic |
| Applicant | CARL ZEISS SURGICAL GMBH 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Judith Brimacombe |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-18 |
| Decision Date | 2010-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539102362 | K100468 | 000 |
| 04049539070128 | K100468 | 000 |