The following data is part of a premarket notification filed by Surgvision Gmbh with the FDA for Explorer Air Ii.
| Device ID | K214097 |
| 510k Number | K214097 |
| Device Name: | Explorer Air II |
| Classification | System, X-ray, Angiographic |
| Applicant | SurgVision GmbH Kistlerhof Strasse 70, Building 79 Munich, DE 81379 |
| Contact | Daniela Mahan |
| Correspondent | Daniela Mahan SurgVision GmbH Kistlerhof Strasse 70, Building 79 Munich, DE 81379 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-28 |
| Decision Date | 2022-02-25 |