ECG ELECTRODE SYSTEM— 510(k) K873442

Substantially Equivalent

Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S

FDA 510(k) clearance K873442 for ECG ELECTRODE SYSTEM, Substantially Equivalent on 1987-11-23. Applicant: Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S.

Clearance details

Applicant: Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1987-08-27
Decision date: 1987-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.