3 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
FDA Enforcement
Class II
·Terminated·Circadiance LLC·June 14, 2017
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
FDA Enforcement
Class II
·Terminated·Childrens Medical Ventures·June 25, 2014
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024