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FDA 510(k) Application Details - K131099
Device Classification Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
More FDA Info for this Device
510(K) Number
K131099
Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant
HOSPITECH RESPIRATION LTD.
31 HAAVODA ST
BINYAMINA 30500 IL
Other 510(k) Applications for this Company
Contact
YORAM LEVY
Other 510(k) Applications for this Contact
Regulation Number
878.4780
More FDA Info for this Regulation Number
Classification Product Code
JCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/19/2013
Decision Date
05/13/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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