KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS— 510(k) K011859
Substantially EquivalentKlimamed Technologie Medizingerate GmbH
FDA 510(k) clearance K011859 for KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS, Substantially Equivalent on 2002-05-01. Applicant: Klimamed Technologie Medizingerate GmbH.
Clearance details
- Applicant
- Klimamed Technologie Medizingerate GmbH
- Product code
- Code DWJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseville, CA, US
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
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.