Presson Electrode
FDA 510(k) K103103 · Persyst Development Corp.
510(k) numberK103103
Submission
- Device name
- Presson Electrode
- Applicant
- Persyst Development Corp.
Prescott, AZ, US - Received
- October 20, 2010
- Decision date
- December 8, 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 Presson Electrode cleared by the FDA?
Presson Electrode (K103103) received a 510(k) decision of Substantially Equivalent on December 8, 2011, 414 days after the submission was received.
What is the product code of K103103?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.