The Electrode Store Surface (Cutaneous) Electrode for Emg
FDA 510(k) K020445 · The Electrode Store, Inc.
510(k) numberK020445
Submission
- Device name
- The Electrode Store Surface (Cutaneous) Electrode for Emg
- Applicant
- The Electrode Store, Inc.
Seattle, WA, US - Received
- February 11, 2002
- Decision date
- May 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was The Electrode Store Surface (Cutaneous) Electrode for Emg cleared by the FDA?
The Electrode Store Surface (Cutaneous) Electrode for Emg (K020445) received a 510(k) decision of Substantially Equivalent on May 10, 2002, 88 days after the submission was received.
What is the product code of K020445?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.