NEOS - PULSE GENERATOR— 510(k) K844812

Substantially Equivalent

Biotronik Sales, Inc.

FDA 510(k) clearance K844812 for NEOS - PULSE GENERATOR, Substantially Equivalent on 1985-04-18. Applicant: Biotronik Sales, Inc..

Clearance details

Applicant: Biotronik Sales, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1984-12-11
Decision date: 1985-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, 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.