The following data is part of a premarket notification filed by Helmer Labs., Inc. with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK940051 |
| 510k Number | BK940051 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Helmer Labs., Inc. 5415 Distribution Drive Fort Wayne, IN 46825 |
| 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 | 1994-09-13 |
| Decision Date | 1995-03-03 |