The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Compact 7600.
Device ID | K950781 |
510k Number | K950781 |
Device Name: | COMPACT 7600 |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
Contact | Ted L Parrot |
Correspondent | Ted L Parrot GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-21 |
Decision Date | 1995-06-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COMPACT 7600 75398203 2249092 Dead/Cancelled |
OEC MEDICAL SYSTEMS, INC. 1997-12-01 |