The following data is part of a premarket notification filed by Aerin Medical Inc with the FDA for Vivaer Stylus.
| Device ID | K200300 |
| 510k Number | K200300 |
| Device Name: | VivAer Stylus |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Aerin Medical Inc 232 E Caribbean Dr. Sunnyvale, CA 94089 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull Aerin Medical Inc 232 E Caribbean Dr. Sunnyvale, CA 94089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-06 |
| Decision Date | 2020-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08886479300160 | K200300 | 000 |
| 08886479300269 | K200300 | 000 |