PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D— 510(k) K090671
Substantially EquivalentContec Medical System Co., Ltd.
FDA 510(k) clearance K090671 for PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D, Substantially Equivalent on 2009-06-11. Applicant: Contec Medical System Co., Ltd..
Clearance details
- Applicant
- Contec Medical System Co., Ltd.
- Product code
- Code DQA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhong Shan, Shanghai, CN
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.