The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Freedom Automatic Film Processor.
Device ID | K002640 |
510k Number | K002640 |
Device Name: | FREEDOM AUTOMATIC FILM PROCESSOR |
Classification | Processor, Radiographic-film, Automatic |
Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Contact | Victor Mazzanti |
Correspondent | Victor Mazzanti J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Product Code | IXW |
CFR Regulation Number | 892.1900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-24 |
Decision Date | 2000-11-08 |