FDA 510(k) Application Details - K000599

Device Classification Name Spirometer, Diagnostic

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510(K) Number K000599
Device Name Spirometer, Diagnostic
Applicant VITALOGRAPH, INC.
8347 QUIVIRA RD.
LENEXA, KS 66215 US
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Contact PHIL HEMES
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 02/22/2000
Decision Date 09/08/2000
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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