The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Zeiss Cataract Suite Markerless.
| Device ID | K141068 |
| 510k Number | K141068 |
| Device Name: | ZEISS CATARACT SUITE MARKERLESS |
| 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 |
| Subsequent Product Code | EPT |
| Subsequent Product Code | HMR |
| Subsequent Product Code | HRM |
| Subsequent Product Code | NFJ |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2014-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049539069092 | K141068 | 000 |