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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilatory effort recorder
510(k) Number K982293
Device Name PRESSURE TRANSDUCER AIRFLOW SENSOR
Applicant
PRO-TECH SERVICES, INC.
12826 N.W. 178TH ST., SUITE A
P.O. BOX 2165
WOODINVILLE,  WA  98072
Applicant Contact ANTHONY ZARAGOZA
Correspondent
PRO-TECH SERVICES, INC.
12826 N.W. 178TH ST., SUITE A
P.O. BOX 2165
WOODINVILLE,  WA  98072
Correspondent Contact ANTHONY ZARAGOZA
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/01/1998
Decision Date 07/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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