Blood And Plasma Warming Devices

Device, Warming. Blood And Plasma

CytoTherm LP

The following data is part of a premarket notification filed by Cytotherm Lp with the FDA for Blood And Plasma Warming Devices.

Pre-market Notification Details

Device IDBK960012
510k NumberBK960012
Device Name:Blood And Plasma Warming Devices
ClassificationDevice, Warming. Blood And Plasma
Applicant CytoTherm LP 110 Sewell Avenue Trenton,  NJ  08610 US
Product CodeKZL  
CFR Regulation Number864.9205 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-03
Decision Date1996-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00861128000309 BK960012 0

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