Star 60— 510(k) K151512

Substantially Equivalent

Skanray Technologies Private Limited

FDA 510(k) clearance K151512 for Star 60, Substantially Equivalent on 2016-02-14. Applicant: Skanray Technologies Private Limited.

Clearance details

Applicant: Skanray Technologies Private Limited
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2015-06-04
Decision date: 2016-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mysore, IN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.