The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Iolmaster 700.
Device ID | K173771 |
510k Number | K173771 |
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 | Lisa Graney Biologics Consulting Group, Inc. 1555 King Street, Suite 300 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 | 2017-12-11 |
Decision Date | 2018-08-24 |