HAMILTON-C3— 510(k) K161450
Substantially EquivalentHamilton Medical AG
FDA 510(k) clearance K161450 for HAMILTON-C3, Substantially Equivalent on 2017-04-27. Applicant: Hamilton Medical AG. Device class: 2.
Clearance details
- Applicant
- Hamilton Medical AG
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonaduz, CH
Recent devices under product code CBK
view allMore clearances from Hamilton Medical AG
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 →
Recalls naming K161450
K-number listed on FDA's recall record- Z-1372-2018 — Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
- Z-2796-2018 — Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161450.
Data sourced from openFDA. This site is unofficial and independent of the FDA.