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FDA 510(k) Application Details - K000599
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K000599
Device Name
Spirometer, Diagnostic
Applicant
VITALOGRAPH, INC.
8347 QUIVIRA RD.
LENEXA, KS 66215 US
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PHIL HEMES
Other 510(k) Applications for this Contact
Regulation Number
868.1840
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Classification Product Code
BZG
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More FDA Info for this Product Code
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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