The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Ht-res Rtp System.
Device ID | K894706 |
510k Number | K894706 |
Device Name: | HT-RES RTP SYSTEM |
Classification | Accelerator, Linear, Medical |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Larry Hernandez |
Correspondent | Larry Hernandez ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-24 |
Decision Date | 1989-10-11 |