Cadwell Excel
FDA 510(k) K880088 · Cadwell Laboratories, Inc.
510(k) numberK880088
Submission
- Device name
- Cadwell Excel
- Applicant
- Cadwell Laboratories, Inc.
Kennewick, WA, US - Received
- January 12, 1988
- Decision date
- May 4, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Cadwell Excel cleared by the FDA?
Cadwell Excel (K880088) received a 510(k) decision of Substantially Equivalent on May 4, 1988, 113 days after the submission was received.
What is the product code of K880088?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.