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510(k) K191013

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option by Welch Allyn, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2019
Date Received
April 17, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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