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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K213867
Device Name Carestation 750/750c
Applicant
Datex-Ohmeda, Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Applicant Contact Kimberly Mangum
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Dr., P.O.Box 7550
Madison,  WI  53707 -7550
Correspondent Contact Kimberly Mangum
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received12/10/2021
Decision Date 03/28/2023
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
Recalls CDRH Recalls
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