The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Uroview Model 2600.
Device ID | K940295 |
510k Number | K940295 |
Device Name: | UROVIEW MODEL 2600 |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | GE DEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
Contact | Thomas R Meyers |
Correspondent | Thomas R Meyers 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 | 1994-01-21 |
Decision Date | 1994-08-22 |