The following data is part of a premarket notification filed by Ge Medical Systems,llc (ge Healthcare) with the FDA for Air Recon Dl.
| Device ID | K213717 |
| 510k Number | K213717 |
| Device Name: | AIR Recon DL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE Medical Systems,LLC (GE Healthcare) 3200 N Grandview Blvd Waukesha, WI 53188 |
| Contact | Glen Sabin |
| Correspondent | Glen Sabin GE Medical Systems,LLC (GE Healthcare) 3200 N Grandview Blvd Waukesha, WI 53188 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-24 |
| Decision Date | 2022-06-08 |