FDA.reportPublic FDA data

510(k) K230375

Device
BIOMONITOR IV
Applicant
Biotronik, Inc.
510(k) number
K230375
Product code
MXD
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-19
Date received
2023-02-13
Regulation
870.1025
Classification name
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jon Brumbaugh
Address
6024 Jean Rd. Lake Oswego OR US 97035 97035

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MXD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261074BIOMONITOR IV (471155)Biotronik, Inc.2026-05-01
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K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott2025-09-17
K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation2025-09-12
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K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp2023-08-19
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K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.2021-07-22
K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.2021-06-11
K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.2021-05-28