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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 K210384
Device Name CARESCAPE R860
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Applicant Contact Trishia Mercier
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Correspondent Contact Monica Morrison
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/09/2021
Decision Date 11/04/2021
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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