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FDA 510(k)

BioMonitor 2-AF, BioMonitor 2-S

K-Number: K152995 · 2016-04-11

ApplicantBiotronik, Inc.
Decision Date2016-04-11
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BioMonitor 2-AF, BioMonitor 2-S is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2016-04-11 under 510(k) number K152995. 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 2-AF, BioMonitor 2-S?

BioMonitor 2-AF, BioMonitor 2-S is a medical device that received FDA 510(k) clearance on 2016-04-11. The listed applicant is Biotronik, Inc.. The 510(k) number is K152995.

When did BioMonitor 2-AF, BioMonitor 2-S receive FDA 510(k) clearance?

BioMonitor 2-AF, BioMonitor 2-S received FDA 510(k) clearance on 2016-04-11, under 510(k) number K152995.

Who is the listed applicant for BioMonitor 2-AF, BioMonitor 2-S?

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 2-AF, BioMonitor 2-S?

The FDA product code for BioMonitor 2-AF, BioMonitor 2-S is MXD.

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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.

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