The following data is part of a premarket notification filed by Level 1 Technologies, Inc. with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK920021 |
| 510k Number | BK920021 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Level 1 Technologies, Inc. 160 Weymouth Street Rockland, MA 02370 |
| 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 | 1992-07-29 |
| Decision Date | 1993-01-29 |