PMT Truscan Surface Electrode
FDA 510(k) K122376 · Pmt Corp.
510(k) numberK122376
Submission
- Device name
- PMT Truscan Surface Electrode
- Applicant
- Pmt Corp.
Chanhassen, MN, US - Received
- August 6, 2012
- Decision date
- December 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was PMT Truscan Surface Electrode cleared by the FDA?
PMT Truscan Surface Electrode (K122376) received a 510(k) decision of Substantially Equivalent on December 19, 2012, 135 days after the submission was received.
What is the product code of K122376?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.