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FDA 510(k) Application Details - K991412
Device Classification Name
Meter, Peak Flow, Spirometry
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510(K) Number
K991412
Device Name
Meter, Peak Flow, Spirometry
Applicant
VITALOGRAPH, INC.
8347 QUIVIRA RD.
LENEXA, KS 66215 US
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Contact
PHIL HEMES
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Regulation Number
868.1860
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Classification Product Code
BZH
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More FDA Info for this Product Code
Date Received
04/23/1999
Decision Date
02/04/2000
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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