TRACKER 2/TRACKER 3 HOLTER RECORDER— 510(k) K943278

Substantially Equivalent

Reynolds Medical , Ltd.

FDA 510(k) clearance K943278 for TRACKER 2/TRACKER 3 HOLTER RECORDER, Substantially Equivalent on 1994-10-20. Applicant: Reynolds Medical , Ltd..

Clearance details

Applicant: Reynolds Medical , Ltd.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1994-07-07
Decision date: 1994-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hertford, GB

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.