DR300 HOLTER MONITOR— 510(k) K142424

Substantially Equivalent

North East Monitoring, Inc.

FDA 510(k) clearance K142424 for DR300 HOLTER MONITOR, Substantially Equivalent on 2014-11-25. Applicant: North East Monitoring, Inc..

Clearance details

Applicant: North East Monitoring, Inc.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2014-08-29
Decision date: 2014-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maynard, MA, 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.