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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K920121
Device Name SECHRIST IV-100B SAVI SYSTEM
Applicant
SECHRIST
4225 EAST LA PALMA AVE.
ANAHEIM,  CA  92807
Applicant Contact LEE ADAIR
Correspondent
SECHRIST
4225 EAST LA PALMA AVE.
ANAHEIM,  CA  92807
Correspondent Contact LEE ADAIR
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/13/1992
Decision Date 02/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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