2 results
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7ms
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Sources: EU EUDAMED, US FDA
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 20, 2022
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024