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BIOMONITOR IV — Biotronik, Inc. (510(k) K230375)

BIOMONITOR IV — Biotronik, Inc. (510(k) K230375) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: BIOMONITOR IV; Applicant: Biotronik, Inc.; Clearance track: 510(k).

Device nameBIOMONITOR IV
ApplicantBiotronik, Inc.
Clearance track510(k)
Submission numberK230375
DecisionSubstantially Equivalent
Decision date2023-05-19
Date received2023-02-13
Product codeMXD
Device class2
Medical specialtyCardiovascular
Applicant locationOR, US
SourceopenFDA device

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