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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K141582
Device Name CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
Applicant
WELCH ALLYN
4341 STATE STREET ROAD
SKANEATELES FALLS,  NY  13153
Applicant Contact KEVIN CROSSEN
Correspondent
WELCH ALLYN
4341 STATE STREET ROAD
SKANEATELES FALLS,  NY  13153
Correspondent Contact KEVIN CROSSEN
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
BZG  
Date Received06/13/2014
Decision Date 07/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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