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FDA 510(k) Application Details - K091412
Device Classification Name
Meter, Peak Flow, Spirometry
More FDA Info for this Device
510(K) Number
K091412
Device Name
Meter, Peak Flow, Spirometry
Applicant
VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG 97204 DE
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Contact
THOMAS RUST
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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
05/13/2009
Decision Date
08/21/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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