Dantec 13L35/36/37 Stim. and Recording Electrode
FDA 510(k) K874735 · Dantec Electronics, Inc.
510(k) numberK874735
Submission
- Device name
- Dantec 13L35/36/37 Stim. and Recording Electrode
- Applicant
- Dantec Electronics, Inc.
Allendale, NJ, US - Received
- November 18, 1987
- Decision date
- January 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Dantec 13L35/36/37 Stim. and Recording Electrode cleared by the FDA?
Dantec 13L35/36/37 Stim. and Recording Electrode (K874735) received a 510(k) decision of Substantially Equivalent on January 22, 1988, 65 days after the submission was received.
What is the product code of K874735?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.