The following data is part of a premarket notification filed by Neuwave Medical, Inc with the FDA for Certus 140 2.45ghz Ablation System.
| Device ID | K160936 |
| 510k Number | K160936 |
| Device Name: | Certus 140 2.45GHz Ablation System |
| Classification | System, Ablation, Microwave And Accessories |
| 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 | NEY |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-04 |
| Decision Date | 2016-05-04 |
| Summary: | summary |