Promontory Stimulating Electrode
FDA 510(k) K895081 · Cadwell Laboratories, Inc.
510(k) numberK895081
Submission
- Device name
- Promontory Stimulating Electrode
- Applicant
- Cadwell Laboratories, Inc.
Kennewick, WA, US - Received
- August 14, 1989
- Decision date
- November 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Promontory Stimulating Electrode cleared by the FDA?
Promontory Stimulating Electrode (K895081) received a 510(k) decision of Substantially Equivalent on November 9, 1989, 87 days after the submission was received.
What is the product code of K895081?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.