The following data is part of a premarket notification filed by Erbe Elektromedizin Gmbh with the FDA for Erbecryo 2 Cryosurgical Unit; Erbecryo 2 1-pedal Footswitch, Extension Cable F. Erbecryo 2 Footswitch; Flexible Cryoprobe; Erbecryo 2 Cart, Vio-cart, Wire Basket; Connecting Hoses, Switching Valves, Adapter.
| Device ID | K190651 |
| 510k Number | K190651 |
| Device Name: | ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal Footswitch, Extension Cable F. ERBECRYO 2 Footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire Basket; Connecting Hoses, Switching Valves, Adapter |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | Erbe Elektromedizin GmbH Waldhoernlestrasse 17 Tuebingen, DE 72072 |
| Contact | Julia Weller |
| Correspondent | Henry Kutz Erbe Elektromedizin GmbH Waldhoernlestrasse 17 Tuebingen, DE 72072 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-13 |
| Decision Date | 2020-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147021846 | K190651 | 000 |
| 04050147021822 | K190651 | 000 |
| 04050147021808 | K190651 | 000 |
| 04050147021785 | K190651 | 000 |
| 04050147013797 | K190651 | 000 |
| 04050147019287 | K190651 | 000 |