BIOMECCA CENTRAL CS1— 510(k) K854639

Substantially Equivalent

Biomecca Australia , Ltd.

FDA 510(k) clearance K854639 for BIOMECCA CENTRAL CS1, Substantially Equivalent on 1986-04-17. Applicant: Biomecca Australia , Ltd..

Clearance details

Applicant: Biomecca Australia , Ltd.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1985-11-19
Decision date: 1986-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.