SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR— 510(k) K083010
Substantially EquivalentShenzhen Med-Link Electronics Tech Co., Ltd.
FDA 510(k) clearance K083010 for SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR, Substantially Equivalent on 2009-06-10. Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd..
Clearance details
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd.
- Product code
- Code DQA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nederland, CO, US
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.