FLOWTRON UNIVERSAL, MODEL AC600

Sleeve, Limb, Compressible

HUNTLEIGH HEALTHCARE, INC.

The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Flowtron Universal, Model Ac600.

Pre-market Notification Details

Device IDK010744
510k NumberK010744
Device Name:FLOWTRON UNIVERSAL, MODEL AC600
ClassificationSleeve, Limb, Compressible
Applicant HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown,  NJ  07724 -3327
ContactAudry Witko
CorrespondentAudry Witko
HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown,  NJ  07724 -3327
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-13
Decision Date2002-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055982700146 K010744 000
05055982700139 K010744 000

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