Skynector CPAP Mask— 510(k) K150685
Substantially EquivalentSky Wise Medical Instrument (Shen Zhen) Co., Ltd.
FDA 510(k) clearance K150685 for Skynector CPAP Mask, Substantially Equivalent on 2015-08-24. Applicant: Sky Wise Medical Instrument (Shen Zhen) Co., Ltd..
Clearance details
- Applicant
- Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.
- Product code
- Code BZD
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, Guang Dong, CN
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
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.