FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM— 510(k) K160540

Substantially Equivalent

Flexicare Medical Limited.

FDA 510(k) clearance K160540 for FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM, Substantially Equivalent on 2016-06-23. Applicant: Flexicare Medical Limited..

Clearance details

Applicant: Flexicare Medical Limited.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2016-02-26
Decision date: 2016-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain Ash, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.