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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 K000794
Device Name MODIFICATION TO MARSPO2, MODEL 2001
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
56 CARPENTER LN.
WALLINGFORD,  CT  06492
Applicant Contact ROBERT H SCHIFFMAN
Correspondent
NOVAMETRIX MEDICAL SYSTEMS, INC.
56 CARPENTER LN.
WALLINGFORD,  CT  06492
Correspondent Contact ROBERT H SCHIFFMAN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/13/2000
Decision Date 04/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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