The following data is part of a premarket notification filed by Philips Medical Systems Dmc Gmbh with the FDA for Digitaldiagnost.
Device ID | K210692 |
510k Number | K210692 |
Device Name: | DigitalDiagnost |
Classification | System, X-ray, Stationary |
Applicant | Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
Contact | Supriya Dalvi |
Correspondent | Supriya Dalvi Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 Hamburg, DE 22335 |
Product Code | KPR |
Subsequent Product Code | LLZ |
Subsequent Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-08 |
Decision Date | 2021-04-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIGITALDIAGNOST 76567697 3096082 Live/Registered |
KONINKLIJKE PHILIPS ELECTRONICS N.V. 2003-12-17 |