PULSE GENERATOR MODEL 61 AND 128— 510(k) K790562

Substantially Equivalent

Ela Medical, Inc.

FDA 510(k) clearance K790562 for PULSE GENERATOR MODEL 61 AND 128, Substantially Equivalent on 1979-05-08. Applicant: Ela Medical, Inc..

Clearance details

Applicant: Ela Medical, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1979-03-19
Decision date: 1979-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

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.