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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, Minimal Ventilatory Support, Facility Use
510(k) Number K230173
Device Name Servo-air Lite Ventilator System
Applicant
Maquet Critical Care AB
Rontgenvagen 2
Solna,  SE SE-171 54
Applicant Contact David Ardanius
Correspondent
Getinge
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Barb Smith
Regulation Number868.5895
Classification Product Code
MNT  
Date Received01/20/2023
Decision Date 07/06/2023
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
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