The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Slit Lamps With Sl Cam 5.0 Digital Imaging Solution.
| Device ID | K133476 |
| 510k Number | K133476 |
| Device Name: | SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Sarah Harrington |
| Correspondent | Sarah Harrington CARL ZEISS MEDITEC AG 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 | 2013-11-12 |
| Decision Date | 2014-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471090208 | K133476 | 000 |
| 04049471090185 | K133476 | 000 |
| 04049471090178 | K133476 | 000 |