CP150 ELECTROCARDIOGRAPH

Electrocardiograph

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Cp150 Electrocardiograph.

Pre-market Notification Details

Device IDK131573
510k NumberK131573
Device Name:CP150 ELECTROCARDIOGRAPH
ClassificationElectrocardiograph
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 CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-30
Decision Date2013-07-03
Summary:summary

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