ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER— 510(k) K121775
Substantially EquivalentVital Signs, Inc., A GE Healthcare Company
FDA 510(k) clearance K121775 for ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER, Substantially Equivalent on 2012-11-28. Applicant: Vital Signs, Inc., A GE Healthcare Company. Device class: 2.
Clearance details
- Applicant
- Vital Signs, Inc., A GE Healthcare Company
- Product code
- Code LGZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Totowa, NJ, US
Recent devices under product code LGZ
view allMore clearances from Vital Signs, Inc., A GE Healthcare Company
view allAdverse events under product code LGZ
product code LGZ- Death
- 16
- Malfunction
- 5,916
- Other
- 1
- Total
- 5,933
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.