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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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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