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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: FLL Applicant: GE HEALTHCARE Decision Date To: 04/25/2024
 
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carescape one and carescape dock fo, carescape ecg, carescape temp, carescape pres GE Healthcare K200494 03/29/2020
datex-ohmeda s/5 e-psm(p) module (consisting of e-psm, e-psmp and e-intpsm modules) and accessories GE HEALTHCARE K062576 09/29/2006
disposable temperature, skin and esophageal probes GE HEALTHCARE K051873 09/20/2005
reusable temperature probes (m1024254 skin temperature probe, reusable; m1024247, gp temperature probe, adult, resuable GE HEALTHCARE K050837 04/27/2005
tympanic temperature probe with foam, model m1024233; without foam model m1024237 GE HEALTHCARE K061942 09/29/2006
b40i patient monitor GE HEALTHCARE FINLAND OY K143676 07/31/2015
carescape b450 GE Healthcare Finland Oy K191249 01/24/2020
carescape b450, e-musb GE Healthcare Finland Oy K213363 04/13/2022
carescape b650 GE Healthcare Finland Oy K191149 01/21/2020
carescape b650, e-musb GE Healthcare Finland Oy K213181 04/13/2022
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