The following data is part of a premarket notification filed by Erbe Elektromedizin Gmbh with the FDA for Apc 3 Argon Plasma Coagulation Unit, Vio 3 Electrosurgical Unit, Fiapc Probes, Hybrid Apc, Apcapplicators, Apc Pressure Reducer With Sensor, Vio Cart, Fastening Sets.
| Device ID | K191234 |
| 510k Number | K191234 |
| Device Name: | APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC Probes, Hybrid APC, APCapplicators, APC Pressure Reducer With Sensor, VIO Cart, Fastening Sets |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Erbe Elektromedizin GmbH Waldhoernlestrasse 17 Tuebingen, DE 72072 |
| Contact | Henry Kutz |
| Correspondent | Henry Kutz 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 | 2019-05-08 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147015692 | K191234 | 000 |