The following data is part of a premarket notification filed by Agfa-gevaert, Inc. with the FDA for Curix Capacity Film Center.
Device ID | K832603 |
510k Number | K832603 |
Device Name: | CURIX CAPACITY FILM CENTER |
Classification | Processor, Radiographic-film, Automatic |
Applicant | AGFA-GEVAERT, INC. TEGERNSEER LANDSTRASSE 161 8000 MUCRCHON 90 West Germany, DE |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-29 |
Decision Date | 1983-09-29 |