ULTRASONIC NEBULIZER (MESH TYPE)— 510(k) K121520

Substantially Equivalent

K-Jump Health Co., Ltd.

FDA 510(k) clearance K121520 for ULTRASONIC NEBULIZER (MESH TYPE), Substantially Equivalent on 2013-03-15. Applicant: K-Jump Health Co., Ltd..

Clearance details

Applicant: K-Jump Health Co., Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2012-05-22
Decision date: 2013-03-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: New Taipei, TW

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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.