Electrodes with snap / Electrodes with pigtail
FDA 510(k) K171722 · Shenzhen Konmed Technology Co., Ltd.
510(k) numberK171722
Submission
- Device name
- Electrodes with snap / Electrodes with pigtail
- Applicant
- Shenzhen Konmed Technology Co., Ltd.
Shenzhen, CN - Received
- June 12, 2017
- Decision date
- January 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Electrodes with snap / Electrodes with pigtail cleared by the FDA?
Electrodes with snap / Electrodes with pigtail (K171722) received a 510(k) decision of Substantially Equivalent on January 10, 2018, 212 days after the submission was received.
What is the product code of K171722?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.