PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)— 510(k) K051887
Substantially EquivalentCarleton Life Support Systems, Inc.
FDA 510(k) clearance K051887 for PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF), Substantially Equivalent on 2005-09-27. Applicant: Carleton Life Support Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Carleton Life Support Systems, Inc.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davenport, IA, US
Recent devices under product code CAW
view allMore clearances from Carleton Life Support Systems, Inc.
view allAdverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.