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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 -2301
Applicant Contact DAVID A.C. GREEN
Correspondent
NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA,  KS  66219 -2301
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
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