GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300— 510(k) K921068

Substantially Equivalent

Datrix

FDA 510(k) clearance K921068 for GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300, Substantially Equivalent on 1992-03-30. Applicant: Datrix.

Clearance details

Applicant: Datrix
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1992-03-06
Decision date: 1992-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Escondido, CA, US

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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.