Ring Electrode
FDA 510(k) K933805 · Cadwell Laboratories, Inc.
510(k) numberK933805
Submission
- Device name
- Ring Electrode
- Applicant
- Cadwell Laboratories, Inc.
Kennewick, WA, US - Received
- August 4, 1993
- Decision date
- December 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ring Electrode cleared by the FDA?
Ring Electrode (K933805) received a 510(k) decision of Substantially Equivalent on December 19, 1994, 502 days after the submission was received.
What is the product code of K933805?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.