BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET— 510(k) K132048
Substantially EquivalentMolnlycke Health Care Us, LLC
FDA 510(k) clearance K132048 for BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET, Substantially Equivalent on 2013-11-06. 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
- Traditional
- Location
- Norcross, GA, US
Recent devices under product code DWJ
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view all- K232508 — Barrier EasyWarm Active Self-Warming Blanket
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- K193573 — Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
- K191869 — Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
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.