The following data is part of a premarket notification filed by Erbe Elektromedizin Gmbh with the FDA for Erbe Esu Model Vio Dv With Accessories.
| Device ID | K150364 |
| 510k Number | K150364 |
| Device Name: | ERBE ESU Model VIO DV With Accessories |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE ELEKTROMEDIZIN GMBH WALDHOERNLESTRASSE, 17 Tuebingen, DE 72072 |
| Contact | Axel Retzlaff |
| Correspondent | Axel Retzlaff ERBE ELEKTROMEDIZIN GMBH WALDHOERNLESTRASSE, 17 Tuebingen, DE 72072 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-12 |
| Decision Date | 2016-05-05 |
| Summary: | summary |