The following data is part of a premarket notification filed by Protec Gmbh & Co. Kg with the FDA for Optimax, Compact 2, Optimax 2010, Ecomax.
| Device ID | K091628 |
| 510k Number | K091628 |
| Device Name: | OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | PROTEC GMBH & CO. KG LICHTENBERGER STR. 35 Oberstenfeld, DE 71720 |
| Contact | Jochen Krupp |
| Correspondent | Jochen Krupp PROTEC GMBH & CO. KG LICHTENBERGER STR. 35 Oberstenfeld, DE 71720 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-04 |
| Decision Date | 2009-08-21 |
| Summary: | summary |