The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Iolmaster.
Device ID | K993357 |
510k Number | K993357 |
Device Name: | IOLMASTER |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
Contact | Scott A Margolin |
Correspondent | Scott A Margolin CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-06 |
Decision Date | 2000-03-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IOLMASTER 75608402 2447354 Live/Registered |
CARL ZEISS AG 1998-12-22 |