OMNI~NEB; OMNI~MAX— 510(k) K030396

Substantially Equivalent

B&B Medical Technologies, Inc.

FDA 510(k) clearance K030396 for OMNI~NEB; OMNI~MAX, Substantially Equivalent on 2004-05-07. Applicant: B&B Medical Technologies, Inc..

Clearance details

Applicant: B&B Medical Technologies, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2003-02-06
Decision date: 2004-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Highlands, CA, 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.