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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 K872482
Device Name GAMBRO-ENGSTROM ERICA IV RESPIRATOR
Applicant
GAMBRO, INC.
600 KNIGHTSBRIDGE PKWY.
LINCOLNSHIRE,  IL  60069
Applicant Contact JEFFREY SHIDEMAN,PHD
Correspondent
GAMBRO, INC.
600 KNIGHTSBRIDGE PKWY.
LINCOLNSHIRE,  IL  60069
Correspondent Contact JEFFREY SHIDEMAN,PHD
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/23/1987
Decision Date 03/03/1988
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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