BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
K-Number: K171514 · 2017-06-29
ApplicantBiotronik, Inc.
Decision Date2017-06-29
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2017-06-29 under approval number K171514. 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, FIT - Fast Insert Tool 1 + 2, Set?
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set is a medical device that received FDA 510(k) clearance on 2017-06-29. It is manufactured by Biotronik, Inc.. The 510(k) number is K171514.
When was BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set approved by the FDA?
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set received FDA 510(k) clearance on 2017-06-29, under approval number K171514.
What company makes BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set?
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set is manufactured by Biotronik, Inc..
What is the FDA product code for BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set?
The FDA product code for BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set is MXD.
Other Devices by Biotronik, Inc.
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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.