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FDA 510(k) Application Details - K061627
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K061627
Device Name
Ventilator, Continuous, Facility Use
Applicant
VERSAMED MEDICAL SYSTEMS, INC.
2 BLUE HILL PLAZA
BLDG. 2, 3RD FLOOR
PEARL RIVER, NY 10965 US
Other 510(k) Applications for this Company
Contact
JERRY KORTEN
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/12/2006
Decision Date
06/29/2006
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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