The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Forum Forum Archive Forum Archive & Viewer Forum Assist Match.
Device ID | K122938 |
510k Number | K122938 |
Device Name: | FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH |
Classification | System, Image Management, Ophthalmic |
Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
Contact | Judy Brimacombe |
Product Code | NFJ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-09-24 |
Decision Date | 2012-11-02 |
Summary: | summary |