BioMonitor 2-AF, BioMonitor 2-S
K-Number: K170628 · 2017-03-31
ApplicantBiotronik, Inc.
Decision Date2017-03-31
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 2017-03-31 under approval number K170628. 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 2017-03-31. It is manufactured by Biotronik, Inc.. The 510(k) number is K170628.
When was BioMonitor 2-AF, BioMonitor 2-S approved by the FDA?
BioMonitor 2-AF, BioMonitor 2-S received FDA 510(k) clearance on 2017-03-31, under approval number K170628.
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.