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FDA 510(k) Application Details - K964978
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K964978
Device Name
Oximeter
Applicant
QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL, WA 98021-8906 US
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Contact
MATTHEW HEDLUND
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
DQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/1996
Decision Date
05/21/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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