The following data is part of a premarket notification filed by Boekel Scientific, Inc with the FDA for Device, Warming, Blood And Plasma.
| Device ID | BK100051 |
| 510k Number | BK100051 |
| Device Name: | Device, Warming, Blood And Plasma |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Boekel Scientific, Inc 855 Pennsylvania Blvd. Feasterville, PA 19053 |
| 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 | 2010-08-23 |
| Decision Date | 2011-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863626000201 | BK100051 | 0 |