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 a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2016-04-11 under approval 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. It is manufactured by Biotronik, Inc.. The 510(k) number is K152995.
When was BioMonitor 2-AF, BioMonitor 2-S approved by the FDA?
BioMonitor 2-AF, BioMonitor 2-S received FDA 510(k) clearance on 2016-04-11, under approval number K152995.
What company makes BioMonitor 2-AF, BioMonitor 2-S?
BioMonitor 2-AF, BioMonitor 2-S is manufactured by Biotronik, Inc..
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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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.