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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 NW 178th St., Suite A
Woodinville,  WA  98072
Applicant Contact ANTHONY ZARAGOZA
Correspondent
Pro-Tech Services, Inc.
12826 NW 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
Predetermined Change
Control Plan Authorized
No
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