The following data is part of a premarket notification filed by Thomson-cgr Medical Corp. with the FDA for Mpg-50 X-ray Generator.
Device ID | K873544 |
510k Number | K873544 |
Device Name: | MPG-50 X-RAY GENERATOR |
Classification | Generator, High-voltage, X-ray, Diagnostic |
Applicant | THOMSON-CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
Contact | Jo Lyons |
Correspondent | Jo Lyons THOMSON-CGR MEDICAL CORP. 10150 OLD COLUMBIA RD. Columbia, MD 21046 |
Product Code | IZO |
CFR Regulation Number | 892.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-01 |
Decision Date | 1987-10-26 |