H3+ Holter Recorder
K-Number: K152626 · 2016-02-26
ApplicantMortara Instrument, Inc.
Decision Date2016-02-26
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
H3+ Holter Recorder is a medical device manufactured by Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-02-26 under approval number K152626. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the H3+ Holter Recorder?
H3+ Holter Recorder is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Mortara Instrument, Inc.. The 510(k) number is K152626.
When was H3+ Holter Recorder approved by the FDA?
H3+ Holter Recorder received FDA 510(k) clearance on 2016-02-26, under approval number K152626.
What company makes H3+ Holter Recorder?
H3+ Holter Recorder is manufactured by Mortara Instrument, Inc..
What is the FDA product code for H3+ Holter Recorder?
The FDA product code for H3+ Holter Recorder is MWJ.
Other Devices by Mortara Instrument, Inc.
Related Devices (Code: MWJ)
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.