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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 K063404
Device Name SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
Applicant
MAQUET CRITICAL CARE AB
1140 ROUTE 22 EAST
SUITE 202
BRIDGEWATER,  NJ  08807
Applicant Contact JAMIE YIEH
Correspondent
MAQUET CRITICAL CARE AB
1140 ROUTE 22 EAST
SUITE 202
BRIDGEWATER,  NJ  08807
Correspondent Contact JAMIE YIEH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/09/2006
Decision Date 02/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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