The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for Shimadzu Ud150l-r X-ray High Voltage Generator.
Device ID | K934967 |
510k Number | K934967 |
Device Name: | SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR |
Classification | Generator, High-voltage, X-ray, Diagnostic |
Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Contact | Michael Y Fishback |
Correspondent | Michael Y Fishback SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
Product Code | IZO |
CFR Regulation Number | 892.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-15 |
Decision Date | 1993-12-13 |