ENFLOW IV FLUID WARMER INSULATED STRAP

Warmer, Thermal, Infusion Fluid

VITAL SIGNS, INC., A GE HEALTHCARE COMPANY

The following data is part of a premarket notification filed by Vital Signs, Inc., A Ge Healthcare Company with the FDA for Enflow Iv Fluid Warmer Insulated Strap.

Pre-market Notification Details

Device IDK130867
510k NumberK130867
Device Name:ENFLOW IV FLUID WARMER INSULATED STRAP
ClassificationWarmer, Thermal, Infusion Fluid
Applicant VITAL SIGNS, INC., A GE HEALTHCARE COMPANY 20 CAMPUS RD Totowa,  NJ  07512
ContactStacie Geffner-atiya
CorrespondentStacie Geffner-atiya
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY 20 CAMPUS RD Totowa,  NJ  07512
Product CodeLGZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-28
Decision Date2013-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10190752188624 K130867 000
50190752178289 K130867 000
50190752147100 K130867 000
10190752125803 K130867 000
10190752125780 K130867 000

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