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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 K915564
Device Name SPIROS
Applicant
LIFE SUPPORT PRODUCTS, INC.
ONE MAUCHLY
IRVINE,  CA  92718
Applicant Contact VERNON TRIMBLE
Correspondent
LIFE SUPPORT PRODUCTS, INC.
ONE MAUCHLY
IRVINE,  CA  92718
Correspondent Contact VERNON TRIMBLE
Regulation Number868.5925
Classification Product Code
BTL  
Date Received12/12/1991
Decision Date 01/30/1992
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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