Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Biomonitor III, Biomonitor IIIm

K-Number: K201865 · 2020-12-08

ApplicantBiotronik, Inc.
Decision Date2020-12-08
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Biomonitor III, Biomonitor IIIm is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K201865. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biomonitor III, Biomonitor IIIm?

Biomonitor III, Biomonitor IIIm is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Biotronik, Inc.. The 510(k) number is K201865.

When did Biomonitor III, Biomonitor IIIm receive FDA 510(k) clearance?

Biomonitor III, Biomonitor IIIm received FDA 510(k) clearance on 2020-12-08, under 510(k) number K201865.

Who is the listed applicant for Biomonitor III, Biomonitor IIIm?

The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biomonitor III, Biomonitor IIIm?

The FDA product code for Biomonitor III, Biomonitor IIIm is MXD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05540223Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold SystemACTIVE_NOT_RECRUITINGNCT06540079BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP SCOMPLETEDNCT07091682Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo LesionsRECRUITINGNCT07118358BIOTRONIK Investigation of the LivIQ Leadless Pacemaker SystemRECRUITING

Other records listing Biotronik, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P170030Coronary drug-eluting stentPMA P980023Implantable cardioverter defibrillator (non-CRT)PMA P950037implantable pacemaker Pulse-generatorPMA P050023DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBERPMA P000009DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBERPMA P160025STENT, SUPERFICIAL FEMORAL ARTERY

View all 33 devices →

Related Devices (Code: MXD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261074BIOMONITOR IV (471155)Biotronik, Inc.K253516Assert-IQ (DM5100)ABBOTT MEDICALK251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)AbbottK252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific CorporationK240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑