The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Brivo Nm 615.
| Device ID | K113350 |
| 510k Number | K113350 |
| Device Name: | BRIVO NM 615 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE HEALTHCARE 4 HAYOZMA STREET Tirat Hacarmel, IL 30200 |
| Contact | Eli Werner |
| Correspondent | Eli Werner GE HEALTHCARE 4 HAYOZMA STREET Tirat Hacarmel, IL 30200 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2011-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682139267 | K113350 | 000 |
| 00840682117869 | K113350 | 000 |