The following data is part of a premarket notification filed by Barkey Gmbh & Co Kg with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK100063 |
| 510k Number | BK100063 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Barkey GmbH & Co KG gewerbestrasse 8 d-33818 Leopoldshoehe 33818 Leopoldshoehe, 33818, GM |
| Product Code | KZL |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-27 |
| Decision Date | 2017-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04059201000018 | BK100063 | 0 |
| 04059201000001 | BK100063 | 0 |
| 04059201002135 | BK100063 | 0 |
| 04059201001817 | BK100063 | 0 |
| 04059201001701 | BK100063 | 0 |