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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K850487
Device Name NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER
Applicant
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Applicant Contact PAUL V BUDAX
Correspondent
Novametrix Medical Systems, Inc.
1 Barnes Industrial Park Rd.
P.O. Box 690
Wallingford,  CT  06492
Correspondent Contact PAUL V BUDAX
Regulation Number870.2810
Classification Product Code
DSF  
Date Received02/07/1985
Decision Date 03/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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