The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Digipan.
Device ID | K961826 |
510k Number | K961826 |
Device Name: | DIGIPAN |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
Contact | Marie-pierre Labat-camy |
Correspondent | Marie-pierre Labat-camy TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-13 |
Decision Date | 1996-09-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIGIPAN 79077091 3933776 Dead/Cancelled |
Bernard Anthony Fellowes 2009-12-04 |
DIGIPAN 75108059 2128215 Live/Registered |
CARESTREAM HEALTH, INC. 1996-05-22 |