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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K960851
Device Name THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
Applicant
PRO-TECH SERVICES, INC.
12826 N.W. 178TH ST., SUITE A
WOODINVILLE,  WA  98072
Applicant Contact ANTHONY ZARAGOZA
Correspondent
PRO-TECH SERVICES, INC.
12826 N.W. 178TH ST., SUITE A
WOODINVILLE,  WA  98072
Correspondent Contact ANTHONY ZARAGOZA
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/01/1996
Decision Date 09/17/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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