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FDA 510(k) Application Details - K953238
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K953238
Device Name
Ventilator, Continuous, Facility Use
Applicant
DRAGER, INC.
4101-100 PLEASANT VALLEY RD.
CHANTILLY, VA 22021 US
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Contact
HARALD KNEUER
Other 510(k) Applications for this Contact
Regulation Number
868.5895
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Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/11/1995
Decision Date
09/16/1996
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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