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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 K260326
Device Name Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)
Applicant
Datex-Ohmeda, Inc.
3114 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Isabel McGann
Correspondent
Datex-Ohmeda, Inc.
3114 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Isabel McGann
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
FMT  
Date Received01/30/2026
Decision Date 07/28/2026
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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