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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K251663
Device Name Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
Applicant
Datex-Ohmeda, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Jordan Baum
Correspondent
Datex-Ohmeda, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Jordan Baum
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
FMT  
Date Received05/30/2025
Decision Date 10/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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