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FDA 510(k) Application Details - K142812
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K142812
Device Name
Spirometer, Diagnostic
Applicant
VITALOGRAPH(IRELAND) LTD.
Gort Road Business Park
ENNIS IE
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Contact
Tom J Healy
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
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More FDA Info for this Product Code
Date Received
09/29/2014
Decision Date
06/29/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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