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.. Device class: 2.
Clearance details
- Applicant
- Unimed Medical Supplies, Inc.
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code CCK
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view all- K253162 — Temperature probes (5 models)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (4 models)
- K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48) +1 more
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.