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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 K893622
Device Name PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
Applicant
Preemicare Corp.
3300 Walnut Bend Ln.
Houston,  TX  77042
Applicant Contact CHARLES BOYD
Correspondent
Preemicare Corp.
3300 Walnut Bend Ln.
Houston,  TX  77042
Correspondent Contact CHARLES BOYD
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/11/1989
Decision Date 01/03/1990
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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