The following data is part of a premarket notification filed by In-touch Company with the FDA for Blood And Plasma Warming Devices.
Device ID | BK910033 |
510k Number | BK910033 |
Device Name: | Blood And Plasma Warming Devices |
Classification | Device, Warming. Blood And Plasma |
Applicant | In-Touch Company 101 N 700 West Salt Lake City, UT 84954 |
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 | 1991-12-01 |
Decision Date | 1992-11-18 |