SKYLINE 55— 510(k) K081552

Substantially Equivalent

Larsen & Toubro Limited

FDA 510(k) clearance K081552 for SKYLINE 55, Substantially Equivalent on 2008-07-31. Applicant: Larsen & Toubro Limited.

Clearance details

Applicant: Larsen & Toubro Limited
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2008-06-03
Decision date: 2008-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mysore, Karnataka, 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.