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FDA 510(k) Application Details - K031400
Device Classification Name
Gas-Machine, Anesthesia
More FDA Info for this Device
510(K) Number
K031400
Device Name
Gas-Machine, Anesthesia
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD, PA 18969 US
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Contact
MICHAEL A KELHART
Other 510(k) Applications for this Contact
Regulation Number
868.5160
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Classification Product Code
BSZ
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More FDA Info for this Product Code
Date Received
05/05/2003
Decision Date
07/15/2003
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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