The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Rpm Respiratory Gating System.
Device ID | K063270 |
510k Number | K063270 |
Device Name: | RPM RESPIRATORY GATING SYSTEM |
Classification | Accelerator, Linear, Medical |
Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 |
Contact | Vy Tran |
Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-30 |
Decision Date | 2006-12-14 |
Summary: | summary |