The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Diagnocam.
Device ID | K123402 |
510k Number | K123402 |
Device Name: | DIAGNOCAM |
Classification | Caries Detector, Laser Light, Transmission |
Applicant | KALTENBACH & VOIGT GMBH BISMARCHRING 39 Biberach / Riss, DE 88400 |
Contact | Stefan Trampler |
Correspondent | Stefan Trampler KALTENBACH & VOIGT GMBH BISMARCHRING 39 Biberach / Riss, DE 88400 |
Product Code | NTK |
CFR Regulation Number | 872.1745 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-05 |
Decision Date | 2013-09-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EKAV101055700 | K123402 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIAGNOCAM 79068175 3692898 Dead/Cancelled |
Kaltenbach & Voigt GmbH 2009-03-02 |