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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bed, ac-powered adjustable hospital
510(k) Number K202964
Device Name iBed Wireless with iBed Mobile
Applicant
Stryker Corporation
3800 E. Centre Avenue
Portage,  MI  49002
Applicant Contact Cathy Friday
Correspondent
Stryker Corporation
3800 E. Centre Avenue
Portage,  MI  49002
Correspondent Contact Cathy Friday
Regulation Number880.5100
Classification Product Code
FNL  
Date Received09/30/2020
Decision Date 06/18/2021
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
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