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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 K833982
Device Name MODEL IV 100B-DA INFANT VENTILATOR
Applicant
SECHRIST INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SECHRIST INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/17/1983
Decision Date 03/05/1984
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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