The following data is part of a premarket notification filed by Neuwave Medical Inc. with the FDA for Ablation Confirmation.
| Device ID | K150313 |
| 510k Number | K150313 |
| Device Name: | Ablation Confirmation |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-07-09 |
| Summary: | summary |