STILITH CARDIAC PACEMAKERS-M. 60 & 120— 510(k) K780781

Substantially Equivalent

R.E. Brown Co., Inc.

FDA 510(k) clearance K780781 for STILITH CARDIAC PACEMAKERS-M. 60 & 120, Substantially Equivalent on 1978-07-27. Applicant: R.E. Brown Co., Inc..

Clearance details

Applicant: R.E. Brown Co., Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1978-05-12
Decision date: 1978-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.