The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Blood And Plasma Warming Devices.
Device ID | BK890018 |
510k Number | BK890018 |
Device Name: | Blood And Plasma Warming Devices |
Classification | Device, Warming. Blood And Plasma |
Applicant | Ackrad Laboratories 70 Jackson Dr. Cranford, NJ 07016 |
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 | 1989-08-22 |
Decision Date | 1990-09-21 |