C300 SERIES AIR NEBULIZER COMPRESSOR— 510(k) K062952

Name: FDA 510(k) clearance K062952
Creator: U.S. Food and Drug Administration
Published: 2007-02-21

Substantially Equivalent

Choice Smart Health Care Co. , Ltd.

FDA 510(k) clearance K062952 for C300 SERIES AIR NEBULIZER COMPRESSOR, Substantially Equivalent on 2007-02-21. Applicant: Choice Smart Health Care Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Choice Smart Health Care Co. , Ltd.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 2006-09-29
Decision date: 2007-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAF

view all

K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)2026-06-02
K251572 — eRapid with eTrack System2025-12-19
K251659 — Mesh Nebulizer (H6)2025-11-14
K244035 — Portable mesh nebulizer (JM821)2025-09-19
K243468 — Compressor Nebulizer (4 models)2025-07-02

More clearances from Choice Smart Health Care Co. , Ltd.

view all

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.