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FDA 510(k) Application Details - K000814
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K000814
Device Name
Oximeter
Applicant
BHS INTL., INC.
2431 CROFTON LN., SUITE 9
CROFTON, MD 21114 US
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CHRIS REDDING
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
DQA
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More FDA Info for this Product Code
Date Received
03/13/2000
Decision Date
03/29/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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