The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Brivo Xr385.
| Device ID | K103448 |
| 510k Number | K103448 |
| Device Name: | BRIVO XR385 |
| Classification | System, X-ray, Stationary |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | John L Schmidt |
| Correspondent | John L Schmidt GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2011-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118149 | K103448 | 000 |