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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K213551
Device Name Giraffe Omnibed Carestation CS1
Applicant
Datex Ohmeda Inc.
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Shiwani Zalpuri
Correspondent
Datex Ohmeda Inc.
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Shiwani Zalpuri
Regulation Number880.5130
Classification Product Code
FMT  
Subsequent Product Code
FMZ  
Date Received11/08/2021
Decision Date 03/02/2022
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
Recalls CDRH Recalls
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