The following data is part of a premarket notification filed by Bowa-electronics Gmbh & Co. Kg with the FDA for Arc 400.
| Device ID | K193591 |
| 510k Number | K193591 |
| Device Name: | ARC 400 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOWA-electronics GmbH & Co. KG Heinrich-Hertz-Strasse. 4-10 Gomaringen, DE 72810 |
| Contact | Wolf-ruediger Fritz |
| Correspondent | Roxana Cernescu Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-23 |
| Decision Date | 2020-04-02 |