The following data is part of a premarket notification filed by Microwave Medical System with the FDA for Blood And Plasma Warming Devices.
Device ID | BK970044 |
510k Number | BK970044 |
Device Name: | Blood And Plasma Warming Devices |
Classification | Device, Warming. Blood And Plasma |
Applicant | Microwave Medical System 310-312 School St. Acton, MA 01720 |
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 | 1997-10-31 |
Decision Date | 1998-01-23 |