The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Iolmaster 700.
| Device ID | K170171 |
| 510k Number | K170171 |
| Device Name: | IOLMaster 700 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07445 |
| Contact | Christian Muenster |
| Correspondent | Rahul Ram Biologics Consulting Group, Inc. 400 N. Washington Street, Suite 100 Alexandria, VA 22314 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-19 |
| Decision Date | 2017-04-06 |
| Summary: | summary |