K110398

Substantially Equivalent

RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS

Applicant: Respironics, Inc.
Product code: BZE
Advisory panel: Anesthesiology
Date received: 2011-02-11
Decision date: 2011-06-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Murrysville, PA, US

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.