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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 K103575
Device Name SPIRO PD
Applicant
Pmd Healthcare
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Pmd Healthcare
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/06/2010
Decision Date 11/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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