The following data is part of a premarket notification filed by Ge Healthcare Coils (usa Instruments, Inc.) with the FDA for 3.0t Air Mp M, 3.0t Air Mp L.
| Device ID | K182504 |
| 510k Number | K182504 |
| Device Name: | 3.0T Air MP M, 3.0T Air MP L |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE Healthcare Coils (USA Instruments, Inc.) 1515 Danner Drive Aurora, OH 44202 |
| Contact | Veronica A. Meridith |
| Correspondent | Veronica A. Meridith GE Healthcare Coils (USA Instruments, Inc.) 1515 Danner Drive Aurora, OH 44202 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2018-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682145602 | K182504 | 000 |
| 00840682145589 | K182504 | 000 |