H3+ Holter Recorder— 510(k) K152626

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K152626 for H3+ Holter Recorder, Substantially Equivalent on 2016-02-26. Applicant: Mortara Instrument, Inc..

Clearance details

Applicant: Mortara Instrument, Inc.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2015-09-15
Decision date: 2016-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.