The following data is part of a premarket notification filed by Ge Healthcare Surgery Ge Oec Medical Systems, Inc with the FDA for Oec Brivo 865 Advance, Oec Brivo 785 Essential, And Oec Brivo 715 Prime.
| Device ID | K123603 |
| 510k Number | K123603 |
| Device Name: | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DRIVE Salt Lake City, UT 84116 |
| Contact | Gerald Buss |
| Correspondent | Gerald Buss GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DRIVE 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 | 2012-11-21 |
| Decision Date | 2013-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115438 | K123603 | 000 |
| 00840682115377 | K123603 | 000 |
| 00840682115360 | K123603 | 000 |