The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Linear Accelerator Multiple Exl 3-4-6.
Device ID | K840136 |
510k Number | K840136 |
Device Name: | LINEAR ACCELERATOR MULTIPLE EXL 3-4-6 |
Classification | Accelerator, Linear, Medical |
Applicant | ADAC LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-03 |
Decision Date | 1984-03-16 |