Oscar 2— 510(k) K151520

Substantially Equivalent

Suntech Medical, Inc.

FDA 510(k) clearance K151520 for Oscar 2, Substantially Equivalent on 2016-02-19. Applicant: Suntech Medical, Inc..

Clearance details

Applicant: Suntech Medical, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2015-06-05
Decision date: 2016-02-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.