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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 K973347
Device Name TSX PRM PULMONARY RESUSCITATION MONITOR
Applicant
Spiracle Technology
16520 Harbor Blvd., Unit D
Fountain Valley,  CA  92708
Applicant Contact GUY GANSEL
Correspondent
Spiracle Technology
16520 Harbor Blvd., Unit D
Fountain Valley,  CA  92708
Correspondent Contact GUY GANSEL
Regulation Number868.2600
Classification Product Code
CAP  
Date Received09/05/1997
Decision Date 07/23/1998
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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