The following data is part of a premarket notification filed by Bayer Corp., Agfa Div. with the FDA for Cp 1000, Curix Ht 330, Classic E.o.s., Curix Ht 530, Mamoray Ht 300, Mamoray Cmpact Plus, Curix Compact Plus, Curix Coms.
| Device ID | K981280 |
| 510k Number | K981280 |
| Device Name: | CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | BAYER CORP., AGFA DIV. 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Contact | Michael Sullivan |
| Correspondent | Michael Sullivan BAYER CORP., AGFA DIV. 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-08 |
| Decision Date | 1998-04-30 |
| Summary: | summary |