HOLTER FOR WINDOWS— 510(k) K930564

Name: FDA 510(k) clearance K930564
Creator: U.S. Food and Drug Administration
Published: 1995-04-19

Substantially Equivalent

North East Monitoring, Inc.

FDA 510(k) clearance K930564 for HOLTER FOR WINDOWS, Substantially Equivalent on 1995-04-19. Applicant: North East Monitoring, Inc.. Device class: 2.

Clearance details

Applicant: North East Monitoring, Inc.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 1993-02-03
Decision date: 1995-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sudbury, MA, US

Download summary PDF View on FDA.gov ↗

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K061293 — TELAHEART DIGITAL RECORDER2006-08-25
K041901 — SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER2004-08-31

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.