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FDA 510(k) Application Details - K010093
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K010093
Device Name
Ventilator, Continuous, Facility Use
Applicant
DRAGER MEDIZINTECHNIK GMBH
3136 QUARRY RD.
TELFORD, PA 18969 US
Other 510(k) Applications for this Company
Contact
JAMES J BRENNAN
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
01/11/2001
Decision Date
06/14/2001
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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