SCOLE 300 ECG RECORDER— 510(k) K923664

Substantially Equivalent

Scole Engineering Co.

FDA 510(k) clearance K923664 for SCOLE 300 ECG RECORDER, Substantially Equivalent on 1994-01-13. Applicant: Scole Engineering Co..

Clearance details

Applicant: Scole Engineering Co.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1992-07-22
Decision date: 1994-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, 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.