HUNTLEIGH FLOWPAC FP2000

Compressor, Cardiac, External

HUNTLEIGH TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Huntleigh Flowpac Fp2000.

Pre-market Notification Details

Device IDK871272
510k NumberK871272
Device Name:HUNTLEIGH FLOWPAC FP2000
ClassificationCompressor, Cardiac, External
Applicant HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan,  NJ  07726
ContactJames Britton
CorrespondentJames Britton
HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan,  NJ  07726
Product CodeDRM  
CFR Regulation Number870.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-31
Decision Date1987-06-25

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