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FDA 510(k) Application Details - K071955
Device Classification Name
Calculator, Pulmonary Function Interpretator (Diagnostic)
More FDA Info for this Device
510(K) Number
K071955
Device Name
Calculator, Pulmonary Function Interpretator (Diagnostic)
Applicant
KARMEL SONIX
31 HAAVODA ST.
BINYAMINA IL
Other 510(k) Applications for this Company
Contact
YORAM LEVY
Other 510(k) Applications for this Contact
Regulation Number
868.1900
More FDA Info for this Regulation Number
Classification Product Code
BZM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2007
Decision Date
11/01/2007
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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