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FDA 510(k) Application Details - K090863
Device Classification Name
Calculator, Pulmonary Function Interpretator (Diagnostic)
More FDA Info for this Device
510(K) Number
K090863
Device Name
Calculator, Pulmonary Function Interpretator (Diagnostic)
Applicant
KARMELSONIX
31 HAAVODA ST.
BINYAMINA IL
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Contact
YORAM LEVY
Other 510(k) Applications for this Contact
Regulation Number
868.1900
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Classification Product Code
BZM
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More FDA Info for this Product Code
Date Received
03/30/2009
Decision Date
09/21/2009
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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