FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001— 510(k) K101552

Substantially Equivalent

Foshan Care Medical Technology Co., Ltd.

FDA 510(k) clearance K101552 for FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001, Substantially Equivalent on 2011-03-14. Applicant: Foshan Care Medical Technology Co., Ltd..

Clearance details

Applicant: Foshan Care Medical Technology Co., Ltd.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2010-06-04
Decision date: 2011-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmichael, 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.