OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE— 510(k) K103625
Substantially EquivalentDraeger Medical Systems, Inc.
FDA 510(k) clearance K103625 for OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE, Substantially Equivalent on 2011-10-06. Applicant: Draeger Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Draeger Medical Systems, Inc.
- 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 Draeger Medical Systems, Inc.
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 K103625
K-number listed on FDA's recall record- Z-2018-2023 — Oxylog 3000 Plus emergency and transport ventilator
- Z-0691-2016 — Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
- Z-0692-2016 — Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
- Z-1440-2014 — Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103625.
Data sourced from openFDA. This site is unofficial and independent of the FDA.