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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, External Body, Negative Pressure, Adult (Cuirass)
510(k) Number K903745
Device Name THE HAYEK OSCILLATOR
Applicant
Flexco Medical Instruments
Kirchweg 151, 8102
Oberengstringen
Zurich, Switzerland,  CH
Applicant Contact EDITH MULLER
Correspondent
Flexco Medical Instruments
Kirchweg 151, 8102
Oberengstringen
Zurich, Switzerland,  CH
Correspondent Contact EDITH MULLER
Regulation Number868.5935
Classification Product Code
BYT  
Date Received08/16/1990
Decision Date 11/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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