PORTABLE OXYGEN UNIT SCA900— 510(k) K080243

Name: FDA 510(k) clearance K080243
Creator: U.S. Food and Drug Administration
Published: 2009-04-07

Substantially Equivalent

San Cheong Co. , Ltd.

FDA 510(k) clearance K080243 for PORTABLE OXYGEN UNIT SCA900, Substantially Equivalent on 2009-04-07. Applicant: San Cheong Co. , Ltd.. Device class: 1.

Clearance details

Applicant: San Cheong Co. , Ltd.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 2008-01-31
Decision date: 2009-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAN

view all

K162811 — MR Conditional CGA 8702017-03-02
K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR2006-10-25
K061785 — CYL-FIL OXYGEN SYSTEM2006-09-07
K950777 — OXYGEN REGULATOR1995-04-14
K942751 — VANGUARD SERIES GAS REGULATORS1995-02-09

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.