MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS— 510(k) K014301
Substantially EquivalentMerits Health Products Co., Ltd.
FDA 510(k) clearance K014301 for MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS, Substantially Equivalent on 2002-02-11. Applicant: Merits Health Products Co., Ltd..
Clearance details
- Applicant
- Merits Health Products Co., Ltd.
- Product code
- Code CAW
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fort Myers, FL, US
Adverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
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.