INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE— 510(k) K093633
Substantially EquivalentDraegerwerk AG & CO Kgaa
FDA 510(k) clearance K093633 for INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE, Substantially Equivalent on 2010-03-30. Applicant: Draegerwerk AG & CO Kgaa. Device class: 2.
Clearance details
- Applicant
- Draegerwerk AG & CO Kgaa
- 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
- Lübeck, DE
Recent devices under product code CBK
view allMore clearances from Draegerwerk AG & CO Kgaa
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 K093633
K-number listed on FDA's recall record- Z-0870-2022 — Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
- Z-0108-2022 — Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
- Z-0827-2016 — Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
- Z-0436-2016 — Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
- Z-2343-2015 — PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
- Z-1298-2014 — Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093633.
Data sourced from openFDA. This site is unofficial and independent of the FDA.