The following data is part of a premarket notification filed by Prowess Inc. with the FDA for Panther Ois.
| Device ID | K211760 |
| 510k Number | K211760 |
| Device Name: | Panther OIS |
| Classification | Accelerator, Linear, Medical |
| Applicant | Prowess Inc. 1844 Clayton Road Concord, CA 94520 |
| Contact | Rachel Scarano |
| Correspondent | Rachel Scarano Prowess Inc. 1844 Clayton Road Concord, CA 94520 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-08 |
| Decision Date | 2021-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859032007156 | K211760 | 000 |