MICROSTREAM EXTERNAL BATTERY CHARGER— 510(k) K002163

Substantially Equivalent

Oridion Medical 1987 , Ltd.

FDA 510(k) clearance K002163 for MICROSTREAM EXTERNAL BATTERY CHARGER, Substantially Equivalent on 2001-01-11. Applicant: Oridion Medical 1987 , Ltd..

Clearance details

Applicant: Oridion Medical 1987 , Ltd.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2000-07-18
Decision date: 2001-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.