The following data is part of a premarket notification filed by Neuwave Medical, Inc. with the FDA for Ablation Confirmation.
| Device ID | K161285 |
| 510k Number | K161285 |
| Device Name: | Ablation Confirmation |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NEUWAVE MEDICAL, INC. 3529 ANDERSON STREET Madison, WI 53704 |
| Contact | Dan Kosednar |
| Correspondent | Dan Kosednar NEUWAVE MEDICAL, INC. 3529 ANDERSON STREET Madison, WI 53704 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-09 |
| Decision Date | 2016-06-29 |
| Summary: | summary |