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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 K924341
Device Name HAYEK OSCILLATOR(TM)
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Applicant Contact RICHARD G CONFER
Correspondent
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Correspondent Contact RICHARD G CONFER
Regulation Number868.5935
Classification Product Code
BYT  
Subsequent Product Code
BYI  
Date Received08/27/1992
Decision Date 07/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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