HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5— 510(k) K072163

Substantially Equivalent

3A Health Care S.R.L.

FDA 510(k) clearance K072163 for HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5, Substantially Equivalent on 2008-03-06. Applicant: 3A Health Care S.R.L..

Clearance details

Applicant: 3A Health Care S.R.L.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2007-08-06
Decision date: 2008-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, 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.