The following data is part of a premarket notification filed by Thermogenesis with the FDA for Blood Mixing And Weighing Devices.
Device ID | BK960074 |
510k Number | BK960074 |
Device Name: | Blood Mixing And Weighing Devices |
Classification | Device, Blood Mixing And Blood Weighing |
Applicant | Thermogenesis 3146 Gold Camp Drive suite 206 Rancho Cordova, CA 95670 |
Product Code | KSQ |
CFR Regulation Number | 864.9195 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-03 |
Decision Date | 1997-04-03 |