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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 K073179
Device Name SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
Applicant
Maquet Critical Care AB
1140 Route 22 E.
Suite 202
Bridgewater,  NJ  08807
Applicant Contact JAMIE YIEH
Correspondent
Maquet Critical Care AB
1140 Route 22 E.
Suite 202
Bridgewater,  NJ  08807
Correspondent Contact JAMIE YIEH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/13/2007
Decision Date 06/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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