The following data is part of a premarket notification filed by Protec Gmbh & Co. Kg with the FDA for Optimax/ Compact 2.
| Device ID | K992818 |
| 510k Number | K992818 |
| Device Name: | OPTIMAX/ COMPACT 2 |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | PROTEC GMBH & CO. KG LICHTENBERGER STR. 35 Oberstenfeld, DE 71720 |
| Correspondent | Carole Stamp UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-08-20 |
| Decision Date | 1999-09-01 |
| Summary: | summary |