HOLTER RECORDER H3+— 510(k) K043010

Substantially Equivalent

Mortara Instrument, Inc.

FDA 510(k) clearance K043010 for HOLTER RECORDER H3+, Substantially Equivalent on 2005-02-25. Applicant: Mortara Instrument, Inc..

Clearance details

Applicant: Mortara Instrument, Inc.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2004-11-01
Decision date: 2005-02-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Milwaukee, WI, US

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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.