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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 Drive, PO Box 7550
Madison,  WI  53707 -7550
Applicant Contact Kimberly Mangum
Correspondent
Datex-Ohmeda, Inc.
3030 Ohmeda Drive, PO 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
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