Emg Recording Electrode Assembly
FDA 510(k) K120342 · Rhythmlink International, LLC
510(k) numberK120342
Submission
- Device name
- Emg Recording Electrode Assembly
- Applicant
- Rhythmlink International, LLC
Columbia, SC, US - Received
- February 3, 2012
- Decision date
- June 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKT – Electrode, Needle, Diagnostic Electromyograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1385
- Specialty
- Physical Medicine
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Questions and answers
When was Emg Recording Electrode Assembly cleared by the FDA?
Emg Recording Electrode Assembly (K120342) received a 510(k) decision of Substantially Equivalent on June 22, 2012, 140 days after the submission was received.
What is the product code of K120342?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.