The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Artemis Eye System.
| Device ID | K190719 |
| 510k Number | K190719 |
| Device Name: | Artemis Eye System |
| Classification | Endoscope, Neurological |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Aditi Kolla |
| Correspondent | Aditi Kolla Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-20 |
| Decision Date | 2019-08-30 |