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FDA 510(k) Application Details - K081823
Device Classification Name
Plethysmograph, Pressure
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510(K) Number
K081823
Device Name
Plethysmograph, Pressure
Applicant
VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG 97204 DE
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Contact
THOMAS RUST
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Regulation Number
868.1750
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Classification Product Code
CCM
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More FDA Info for this Product Code
Date Received
06/27/2008
Decision Date
05/18/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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