VITALINE DISPOSABLE EKG ELECTRODE-LEAD— 510(k) K821535

Substantially Equivalent

The Halverstadt Co.

FDA 510(k) clearance K821535 for VITALINE DISPOSABLE EKG ELECTRODE-LEAD, Substantially Equivalent on 1982-07-08. Applicant: The Halverstadt Co..

Clearance details

Applicant: The Halverstadt Co.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1982-05-24
Decision date: 1982-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.