The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Dps-33,000 With Centor Option.
Device ID | K881017 |
510k Number | K881017 |
Device Name: | DPS-33,000 WITH CENTOR OPTION |
Classification | System, Image Processing, Radiological |
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 | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-10 |
Decision Date | 1988-08-11 |