The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Adac Models Xl-plan 23 & Xl-plan 73.
Device ID | K851041 |
510k Number | K851041 |
Device Name: | ADAC MODELS XL-PLAN 23 & XL-PLAN 73 |
Classification | Accelerator, Linear, Medical |
Applicant | ADAC LABORATORIES 4747 HELLYER AVENUE San Jose , CA 95138 - |
Contact | Rebecca Andersen |
Correspondent | Rebecca Andersen ADAC LABORATORIES 4747 HELLYER AVENUE San Jose , CA 95138 - |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-14 |
Decision Date | 1985-07-18 |