ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR— 510(k) K972371

Substantially Equivalent

Brasamerica Medical Equipment, Inc.

FDA 510(k) clearance K972371 for ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR, Substantially Equivalent on 1997-08-19. Applicant: Brasamerica Medical Equipment, Inc..

Clearance details

Applicant: Brasamerica Medical Equipment, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1997-06-25
Decision date: 1997-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, 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.