The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Yellow 560 Fluorescence Module.
| Device ID | K162991 |
| 510k Number | K162991 |
| Device Name: | YELLOW 560 Fluorescence Module |
| Classification | System, X-ray, Angiographic |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 Jena, DE 07745 |
| Contact | Peter Schrutka-rechtenstamm |
| Correspondent | Mandy Ambrecht Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-10-27 |
| Decision Date | 2017-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539104359 | K162991 | 000 |