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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K180510
Device Name NS 120P-TRS Airway Pressure Gauge
Applicant
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Applicant Contact Doris Walter
Correspondent
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Correspondent Contact Doris Walter
Regulation Number868.2600
Classification Product Code
CAP  
Date Received02/27/2018
Decision Date 05/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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