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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K010451
Device Name NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
56 CARPENTER LN.
WALLINGFORD,  CT  06492
Applicant Contact ROBERT H SCHIFFMAN, R.A.C.
Correspondent
NOVAMETRIX MEDICAL SYSTEMS, INC.
56 CARPENTER LN.
WALLINGFORD,  CT  06492
Correspondent Contact ROBERT H SCHIFFMAN, R.A.C.
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/15/2001
Decision Date 04/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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