The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Sl 220.
| Device ID | K162684 |
| 510k Number | K162684 |
| Device Name: | SL 220 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | Carl Zeiss Meditec AG Jena, DE 07745 |
| Contact | Christian Muenster |
| Correspondent | Mandy Ambrecht Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-26 |
| Decision Date | 2017-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471097078 | K162684 | 000 |