NEOS 02— 510(k) K894240

Substantially Equivalent

Biotronik Cardiac Pacemakers

FDA 510(k) clearance K894240 for NEOS 02, Substantially Equivalent on 1989-10-26. Applicant: Biotronik Cardiac Pacemakers.

Clearance details

Applicant: Biotronik Cardiac Pacemakers
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1989-06-20
Decision date: 1989-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, CA, 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.