The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Model Arc-st, Pc Style Data Processing System.
Device ID | K874473 |
510k Number | K874473 |
Device Name: | ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM |
Classification | System, Tomographic, Nuclear |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Gary L Pembroke |
Correspondent | Gary L Pembroke ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Product Code | JWM |
CFR Regulation Number | 892.1310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-02 |
Decision Date | 1988-07-18 |