HAMILTON-T1, HAMILTON-C1— 510(k) K181216
Substantially EquivalentHamilton Medical AG
FDA 510(k) clearance K181216 for HAMILTON-T1, HAMILTON-C1, Substantially Equivalent on 2019-08-02. 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 K181216
K-number listed on FDA's recall record- Z-2525-2023 — Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
- Z-2526-2023 — Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
- Z-2527-2023 — Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
- Z-2139-2023 — HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
- Z-2140-2023 — HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181216.
Data sourced from openFDA. This site is unofficial and independent of the FDA.