INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE— 510(k) K093632
Substantially EquivalentDrager Medical AG & Co. Kgaa
FDA 510(k) clearance K093632 for INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE, Substantially Equivalent on 2010-04-05. Applicant: Drager Medical AG & Co. Kgaa. Device class: 2.
Clearance details
- Applicant
- Drager Medical 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
- Telford, PA, US
Recent devices under product code CBK
view allMore clearances from Drager Medical 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 K093632
K-number listed on FDA's recall record- Z-0871-2022 — Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
- Z-0109-2022 — Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
- 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 K093632.
Data sourced from openFDA. This site is unofficial and independent of the FDA.