The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Rfa-7 Radiation Field Analyzer.
Device ID | K845007 |
510k Number | K845007 |
Device Name: | RFA-7 RADIATION FIELD ANALYZER |
Classification | Instrument, Quality-assurance, Radiologic |
Applicant | VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
Contact | Milton D Siegel |
Correspondent | Milton D Siegel VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
Product Code | LHO |
CFR Regulation Number | 892.1940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-26 |
Decision Date | 1985-07-01 |