The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Afp 17 X 4 Automatic Film Processor.
Device ID | K925885 |
510k Number | K925885 |
Device Name: | AFP 17 X 4 AUTOMATIC FILM PROCESSOR |
Classification | Processor, Radiographic-film, Automatic |
Applicant | AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
Contact | Randall L Hale |
Correspondent | Randall L Hale AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-16 |
Decision Date | 1993-06-09 |