The following data is part of a premarket notification filed by Erbe Elektromedizin Gmbh with the FDA for Erbe Esu Model Vio 3 With Accessories.
| Device ID | K190823 |
| 510k Number | K190823 |
| Device Name: | Erbe ESU Model VIO 3 With Accessories |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Erbe Elektromedizin GmbH Waldhoernlestrasse 17 Tuebingen, DE 72072 |
| Contact | Julia Weller |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147015685 | K190823 | 000 |
| 04050147007031 | K190823 | 000 |
| 04050147007048 | K190823 | 000 |
| 04050147011489 | K190823 | 000 |
| 04050147014350 | K190823 | 000 |
| 04050147014381 | K190823 | 000 |
| 04050147014404 | K190823 | 000 |
| 04050147014411 | K190823 | 000 |
| 04050147014428 | K190823 | 000 |
| 04050147015128 | K190823 | 000 |
| 04050147015135 | K190823 | 000 |
| 04050147015142 | K190823 | 000 |
| 04050147015708 | K190823 | 000 |
| 04050147015715 | K190823 | 000 |
| 04050147015722 | K190823 | 000 |
| 04050147015746 | K190823 | 000 |
| 04050147015753 | K190823 | 000 |
| 04050147007024 | K190823 | 000 |