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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Monitoring (W/Wo Alarm)
510(k) Number K983274
Device Name STARTRACK INFANT GRAPHICS MONITOR
Applicant
Nellcor Puritan Bennett, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Applicant Contact DAVID A.C. GREEN
Correspondent
Nellcor Puritan Bennett, Inc.
11150 Thompson Ave.
Lenexa,  KS  66219
Correspondent Contact DAVID A.C. GREEN
Regulation Number868.1850
Classification Product Code
BZK  
Date Received09/17/1998
Decision Date 12/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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