BIOMONITOR III, Remote Assistant III
K-Number: K190548 · 2019-07-05
ApplicantBiotronik, Inc.
Decision Date2019-07-05
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BIOMONITOR III, Remote Assistant III is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2019-07-05 under approval number K190548. 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 III, Remote Assistant III?
BIOMONITOR III, Remote Assistant III is a medical device that received FDA 510(k) clearance on 2019-07-05. It is manufactured by Biotronik, Inc.. The 510(k) number is K190548.
When was BIOMONITOR III, Remote Assistant III approved by the FDA?
BIOMONITOR III, Remote Assistant III received FDA 510(k) clearance on 2019-07-05, under approval number K190548.
What company makes BIOMONITOR III, Remote Assistant III?
BIOMONITOR III, Remote Assistant III is manufactured by Biotronik, Inc..
What is the FDA product code for BIOMONITOR III, Remote Assistant III?
The FDA product code for BIOMONITOR III, Remote Assistant III 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.