The following data is part of a premarket notification filed by Pulse Biosciences, Inc. with the FDA for Cellfx System.
| Device ID | K203299 |
| 510k Number | K203299 |
| Device Name: | CellFX System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Pulse Biosciences, Inc. 3957 Point Eden Way Hayward, CA 94545 |
| Contact | William Knape |
| Correspondent | William Knape 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 | 2020-11-09 |
| Decision Date | 2021-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850003231669 | K203299 | 000 |
| 10850003231638 | K203299 | 000 |
| 10850003231607 | K203299 | 000 |
| 00850003231419 | K203299 | 000 |
| 00850003231389 | K203299 | 000 |
| 10850003231652 | K203299 | 000 |
| 10850003231621 | K203299 | 000 |
| 10850003231591 | K203299 | 000 |