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FDA 510(k) Application Details - K102229
Device Classification Name
Calculator, Pulmonary Function Interpretator (Diagnostic)
More FDA Info for this Device
510(K) Number
K102229
Device Name
Calculator, Pulmonary Function Interpretator (Diagnostic)
Applicant
KARMELSONIX
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
08/09/2010
Decision Date
03/04/2011
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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