MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY— 510(k) K091716
Substantially EquivalentMerits Health Products Co., Ltd.
FDA 510(k) clearance K091716 for MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY, Substantially Equivalent on 2010-04-02. Applicant: Merits Health Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Merits Health Products Co., Ltd.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Taichung, TW
Recent devices under product code CAW
view allMore clearances from Merits Health Products Co., Ltd.
view allAdverse 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.