FLEXIPORT ECOCUFF

Blood Pressure Cuff

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Flexiport Ecocuff.

Pre-market Notification Details

Device IDK122058
510k NumberK122058
Device Name:FLEXIPORT ECOCUFF
ClassificationBlood Pressure Cuff
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactKevin Crossen
CorrespondentKevin Crossen
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-13
Decision Date2012-11-05
Summary:summary

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