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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 K993979
Device Name 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 Received11/24/1999
Decision Date 02/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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