K-numberK213234
Device nameCARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
ApplicantGe Medical Systems Information Technologies, Inc.
Product codeMHX
Device classClass II
Decision dateApr 12, 2022
DecisionSubstantially Equivalent
Regulation870.1025
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View the full FDA submission: accessdata.fda.gov

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