FDA 510(k) Application Details - K953948

Device Classification Name Spirometer, Diagnostic

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510(K) Number K953948
Device Name Spirometer, Diagnostic
Applicant FUTUREMED AMERICA, INC.
21732 DEVONSHIRE ST.
CHATSWORTH, CA 91313 US
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Contact MICHAEL DAVIDSON
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 08/16/1995
Decision Date 06/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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