DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET— 510(k) K132202
Substantially EquivalentEnthermics Medical Systems, Inc.
FDA 510(k) clearance K132202 for DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET, Substantially Equivalent on 2013-12-06. Applicant: Enthermics Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Enthermics Medical Systems, Inc.
- 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
- Traditional
- Location
- Menomonee Falls, WI, US
Recent devices under product code LGZ
view allMore clearances from Enthermics Medical Systems, Inc.
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.