The following data is part of a premarket notification filed by Neuwave Medical, Inc. with the FDA for Ablation Confirmation.
| Device ID | K192427 |
| 510k Number | K192427 |
| Device Name: | Ablation Confirmation |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NeuWave Medical, Inc. 3529 Anderson Street Madison, WI 53704 |
| Contact | Neda Chini |
| Correspondent | Neda Chini 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 | 2019-09-05 |
| Decision Date | 2019-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818913020257 | K192427 | 000 |