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FDA 510(k) Application Details - K080921
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K080921
Device Name
Spirometer, Diagnostic
Applicant
CHEST M.I., INC.
4-2-1 YUSHIMA, BUNKYO-KU
TOKYO 113-0034 JP
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Contact
FUMIAKI KANAI
Other 510(k) Applications for this Contact
Regulation Number
868.1840
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Classification Product Code
BZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2008
Decision Date
01/21/2009
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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