BMR Face
FDA 510(k) K103031 · Bio-Medical Research, Ltd.
510(k) numberK103031
Submission
- Device name
- BMR Face
- Applicant
- Bio-Medical Research, Ltd.
Galway, IE - Received
- October 12, 2010
- Decision date
- November 10, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was BMR Face cleared by the FDA?
BMR Face (K103031) received a 510(k) decision of Substantially Equivalent on November 10, 2011, 394 days after the submission was received.
What is the product code of K103031?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.