The following data is part of a premarket notification filed by Pulse Biosciences, Inc. with the FDA for Cellfx System.
| Device ID | K222075 |
| 510k Number | K222075 |
| Device Name: | CellFX System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Pulse Biosciences, Inc. 3957 Point Eden Way Hayward, CA 94545 |
| Contact | Punam Gollamudi |
| Correspondent | Punam Gollamudi Pulse Biosciences, Inc. 3957 Point Eden Way Hayward, CA 94545 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-14 |
| Decision Date | 2022-09-02 |