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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K982225
Device Name SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
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 Number868.5925
Classification Product Code
BTL  
Date Received06/24/1998
Decision Date 10/28/1998
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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