The following data is part of a premarket notification filed by Ge Dec Medical Systems with the FDA for Series 6600 Digital Mobile C-arm.
Device ID | K951765 |
510k Number | K951765 |
Device Name: | SERIES 6600 DIGITAL MOBILE C-ARM |
Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
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 | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-17 |
Decision Date | 1995-05-11 |
Summary: | summary |