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FDA 510(k) Application Details - K010451
Device Classification Name
Oximeter
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510(K) Number
K010451
Device Name
Oximeter
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
56 CARPENTER LN.
WALLINGFORD, CT 06492 US
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Contact
ROBERT H SCHIFFMAN, R.A.C.
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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
02/15/2001
Decision Date
04/25/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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