The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc. with the FDA for Iolmaster700.
Device ID | K143275 |
510k Number | K143275 |
Device Name: | IOLMaster700 |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 -7562 |
Contact | Christine Dunbar |
Correspondent | Christine Dunbar Carl Zeiss Meditec, Inc. 5160 HACIENDA DRIVE Dublin, CA 94568 -7562 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-14 |
Decision Date | 2015-07-10 |
Summary: | summary |