The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Iolmaster 500.
| Device ID | K122418 |
| 510k Number | K122418 |
| Device Name: | IOLMASTER 500 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Judith A Brimacombe |
| Correspondent | Judith A Brimacombe 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 | 2012-08-08 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471092066 | K122418 | 000 |