The following data is part of a premarket notification filed by Kodak-trophy with the FDA for Kodak Models 2100 And 2200.
| Device ID | K060292 |
| 510k Number | K060292 |
| Device Name: | KODAK MODELS 2100 AND 2200 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | KODAK-TROPHY 4 RUE FERDINAND PELLOUTIER CROISSY-BEAUBOURG Marne La Vallee Cedex 2, FR 77 437 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy KODAK-TROPHY 4 RUE FERDINAND PELLOUTIER CROISSY-BEAUBOURG Marne La Vallee Cedex 2, FR 77 437 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2006-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155154256 | K060292 | 000 |
| 60192155154249 | K060292 | 000 |
| 60192155153617 | K060292 | 000 |
| 60192155153600 | K060292 | 000 |
| 60192155153594 | K060292 | 000 |
| 60192155153587 | K060292 | 000 |
| 60192155153570 | K060292 | 000 |
| 60192155153563 | K060292 | 000 |