The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Model Arc-5000, Gamma Camera.
Device ID | K873075 |
510k Number | K873075 |
Device Name: | ADAC MODEL ARC-5000, GAMMA CAMERA |
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 | 1987-08-06 |
Decision Date | 1987-10-30 |