IBED WIRELESS WITH IBED AWARENESS


Device Classification Name

bed, ac-powered adjustable hospital

510(k) Number K103536
Device Name IBED WIRELESS WITH IBED AWARENESS
Applicant
STRYKER CORPORATION
3800 e. centre ave
portage, 
MI 
49002

Applicant Contact diane horwitz
Regulation Number 880.5100
Classification Product Code
FNL  
Date Received 12/01/2010
Decision Date 12/16/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No