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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K873672
Device Name MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD,  CT  06492
Applicant Contact ROBERT E YOCHER
Correspondent
NOVAMETRIX MEDICAL SYSTEMS, INC.
1 BARNES INDUSTRIAL PARK RD.
P.O. BOX 690
WALLINGFORD,  CT  06492
Correspondent Contact ROBERT E YOCHER
Regulation Number870.2910
Classification Product Code
DRG  
Date Received09/11/1987
Decision Date 12/03/1987
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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