The following data is part of a premarket notification filed by Siemens Medical Laboratories, Inc. with the FDA for Beamview & Beamview Plus (aka Project 743).
Device ID | K903139 |
510k Number | K903139 |
Device Name: | BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743) |
Classification | Accelerator, Linear, Medical |
Applicant | SIEMENS MEDICAL LABORATORIES, INC. 4040 NELSON AVE. Concord, CA 94520 |
Contact | Morton, Jr |
Correspondent | Morton, Jr SIEMENS MEDICAL LABORATORIES, INC. 4040 NELSON AVE. Concord, CA 94520 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-17 |
Decision Date | 1990-11-07 |