The following data is part of a premarket notification filed by Ge Oec Medical Systems, Inc. with the FDA for Ge Oec Everview 7500.
Device ID | K051490 |
510k Number | K051490 |
Device Name: | GE OEC EVERVIEW 7500 |
Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
Applicant | GE OEC MEDICAL SYSTEMS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
Contact | Susan Schmidt |
Correspondent | Susan Schmidt GE OEC MEDICAL SYSTEMS, INC. 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 | 2005-06-06 |
Decision Date | 2005-07-07 |
Summary: | summary |