Barrier EasyWarm Active Self-Warming Blanket— 510(k) K232508
Substantially EquivalentMolnlycke Health Care Us, LLC
FDA 510(k) clearance K232508 for Barrier EasyWarm Active Self-Warming Blanket, Substantially Equivalent on 2023-09-15. Applicant: Molnlycke Health Care Us, LLC. Device class: 2.
Clearance details
- Applicant
- Molnlycke Health Care Us, LLC
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Peachtree Corners, GA, US
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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.