Multi-parameter Patient Monitor, models C30— 510(k) K173454
Substantially EquivalentShenzhen Comen Medical Instruments Co.,Ltd
FDA 510(k) clearance K173454 for Multi-parameter Patient Monitor, models C30, Substantially Equivalent on 2018-08-16. Applicant: Shenzhen Comen Medical Instruments Co.,Ltd.
Clearance details
- Applicant
- Shenzhen Comen Medical Instruments Co.,Ltd
- Product code
- Code MHX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.