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

Name: FDA 510(k) clearance K972371
Creator: U.S. Food and Drug Administration
Published: 1997-08-19

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.. Device class: 2.

Clearance details

Applicant: Brasamerica Medical Equipment, Inc.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
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 ↗

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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.