The following data is part of a premarket notification filed by Ge Healthcare Coils (usa Instruments, Inc.) with the FDA for Air Anterior Array, Air Posterior Array.
| Device ID | K172695 |
| 510k Number | K172695 |
| Device Name: | AIR Anterior Array, AIR Posterior Array |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE Healthcare Coils (USA Instruments, Inc.) 1515 Danner Drive Aurora, OH 44202 |
| Contact | Mary A. Mayka |
| Correspondent | Mary A. Mayka 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 | 2017-09-07 |
| Decision Date | 2017-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682138611 | K172695 | 000 |
| 00840682136655 | K172695 | 000 |