Emsi Garment Electrodes
FDA 510(k) K090889 · Emsi
510(k) numberK090889
Submission
- Device name
- Emsi Garment Electrodes
- Applicant
- Emsi
Alexandria, VA, US - Received
- March 31, 2009
- Decision date
- December 4, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Emsi Garment Electrodes cleared by the FDA?
Emsi Garment Electrodes (K090889) received a 510(k) decision of Substantially Equivalent on December 4, 2009, 248 days after the submission was received.
What is the product code of K090889?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.