BIOMONITOR IV
K-Number: K230375 · 2023-05-19
ApplicantBiotronik, Inc.
Decision Date2023-05-19
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BIOMONITOR IV is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2023-05-19 under approval number K230375. 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 IV?
BIOMONITOR IV is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by Biotronik, Inc.. The 510(k) number is K230375.
When was BIOMONITOR IV approved by the FDA?
BIOMONITOR IV received FDA 510(k) clearance on 2023-05-19, under approval number K230375.
What company makes BIOMONITOR IV?
BIOMONITOR IV is manufactured by Biotronik, Inc..
What is the FDA product code for BIOMONITOR IV?
The FDA product code for BIOMONITOR IV is MXD.
Other Devices by Biotronik, Inc.
Related Devices (Code: MXD)
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.