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FDA 510(k) Application Details - K063806
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K063806
Device Name
Ventilator, Continuous, Facility Use
Applicant
SLEEPNET CORPORATION
1050 PERIMETER RD.
MANCHESTER AIR CENTER
MANCHESTER, NH 03103 US
Other 510(k) Applications for this Company
Contact
PAUL CHIESA
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
12/22/2006
Decision Date
05/17/2007
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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