PORTABLE OXYGEN UNIT SCA900— 510(k) K080243
Substantially EquivalentSan Cheong Co. , Ltd.
FDA 510(k) clearance K080243 for PORTABLE OXYGEN UNIT SCA900, Substantially Equivalent on 2009-04-07. Applicant: San Cheong Co. , Ltd..
Clearance details
- Applicant
- San Cheong Co. , Ltd.
- Product code
- Code CAN
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Fe Springs, CA, US
Adverse events under product code CAN
product code CAN- Death
- 4
- Other
- 1
- Total
- 5
Source: openFDA MAUDE database, through . 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.