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FDA 510(k) Application Details - K041223
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
510(K) Number
K041223
Device Name
Ventilator, Continuous, Facility Use
Applicant
MAQUET CRITICAL CARE AB
1140 ROUTE 22 EAST
SUITE 202
BRIDGEWATER, NJ 08807 US
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Contact
JAMIE YIEH
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
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More FDA Info for this Product Code
Date Received
05/10/2004
Decision Date
07/29/2004
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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