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FDA 510(k) Application Details - K080510
Device Classification Name
Calculator, Predicted Values, Pulmonary Function
More FDA Info for this Device
510(K) Number
K080510
Device Name
Calculator, Predicted Values, Pulmonary Function
Applicant
VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG 97204 DE
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Contact
THOMAS RUST
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Regulation Number
868.1890
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Classification Product Code
BTY
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More FDA Info for this Product Code
Date Received
02/25/2008
Decision Date
08/20/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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