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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) 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. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K152626.

When did H3+ Holter Recorder receive FDA 510(k) clearance?

H3+ Holter Recorder received FDA 510(k) clearance on 2016-02-26, under 510(k) number K152626.

Who is the listed applicant for H3+ Holter Recorder?

The FDA 510(k) record lists Mortara Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H3+ Holter Recorder?

The FDA product code for H3+ Holter Recorder is MWJ.

Other records listing Mortara Instrument, Inc. as applicant

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Related Devices (Code: MWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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