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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 K062793
Device Name SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
Applicant
Maquet Critical Care AB
1140 Rte. 22 E.
Suite 202
Bridgewater,  NJ  08807
Applicant Contact JAMIE YIEH
Correspondent
Maquet Critical Care AB
1140 Rte. 22 E.
Suite 202
Bridgewater,  NJ  08807
Correspondent Contact JAMIE YIEH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/18/2006
Decision Date 02/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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