The following data is part of a premarket notification filed by Trophy with the FDA for Cs 8100 Cs 8100 Access.
| Device ID | K120975 |
| 510k Number | K120975 |
| Device Name: | CS 8100 CS 8100 ACCESS |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155313585 | K120975 | 000 |
| 60192155311321 | K120975 | 000 |
| 60192155303067 | K120975 | 000 |
| 60192155303043 | K120975 | 000 |