BPFONE, MODEL UA 767IT— 510(k) K010751

Substantially Equivalent

Medical Monitors Pty Limited

FDA 510(k) clearance K010751 for BPFONE, MODEL UA 767IT, Substantially Equivalent on 2001-06-11. Applicant: Medical Monitors Pty Limited.

Clearance details

Applicant: Medical Monitors Pty Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-03-13
Decision date: 2001-06-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Randwick Nsw, AU

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.