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FDA 510(k) Application Details - K230278
Device Classification Name
Warmer, Infant Radiant
More FDA Info for this Device
510(K) Number
K230278
Device Name
Warmer, Infant Radiant
Applicant
Draeger Medical Systems, Inc.
3135 Quarry Road
Telford, PA 18969 US
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Contact
Karl Nittinger
Other 510(k) Applications for this Contact
Regulation Number
880.5130
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Classification Product Code
FMT
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More FDA Info for this Product Code
Date Received
02/01/2023
Decision Date
05/30/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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