Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+— 510(k) K210019
Substantially EquivalentUnimed Medical Supplies, Inc.
FDA 510(k) clearance K210019 for Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+, Substantially Equivalent on 2021-03-04. Applicant: Unimed Medical Supplies, Inc..
Clearance details
- Applicant
- Unimed Medical Supplies, Inc.
- Product code
- Code CCK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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.