The following data is part of a premarket notification filed by Sopro - Acteon Group with the FDA for Sopix.
Device ID | K142995 |
510k Number | K142995 |
Device Name: | SOPIX |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | SOPRO - ACTEON GROUP Laciotat, FR 13705 |
Contact | Philippe Boyer |
Correspondent | Rick Rosati SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 Mt Laurel, NJ 08054 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-16 |
Decision Date | 2015-08-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOPIX 79012709 3051241 Live/Registered |
SOPRO (SA) 2005-01-28 |