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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K191013
Device Name Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
Applicant
Welch Allyn, Inc.
7865 North 86th St.
Milwaukee,  WI  53224
Applicant Contact Megan Pellenz
Correspondent
Welch Allyn, Inc.
7865 North 86th St.
Milwaukee,  WI  53224
Correspondent Contact Megan Pellenz
Regulation Number868.1840
Classification Product Code
BZG  
Subsequent Product Code
DPS  
Date Received04/17/2019
Decision Date 09/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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