The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Multi-view Processor (mvp).
Device ID | K931184 |
510k Number | K931184 |
Device Name: | MULTI-VIEW PROCESSOR (MVP) |
Classification | System, X-ray, Angiographic |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Paul M Vicha |
Correspondent | Paul M Vicha ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-09 |
Decision Date | 1993-11-02 |