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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 NW 178th St., Suite A
P.O. Box 2165
Woodinville,  WA  98072
Applicant Contact ANTHONY ZARAGOZA
Correspondent
Pro-Tech Services, Inc.
12826 NW 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
Predetermined Change
Control Plan Authorized		 No
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