NEB-U-MASK SYSTEM, MODELS 1895, 1896— 510(k) K080230

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K080230 for NEB-U-MASK SYSTEM, MODELS 1895, 1896, Substantially Equivalent on 2008-06-09. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2008-01-30
Decision date: 2008-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.