40-HZ Auditory Evoked Response Test
FDA 510(k) K862361 · Cadwell Laboratories, Inc.
510(k) numberK862361
Submission
- Device name
- 40-HZ Auditory Evoked Response Test
- Applicant
- Cadwell Laboratories, Inc.
Kennewick, WA, US - Received
- June 23, 1986
- Decision date
- September 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was 40-HZ Auditory Evoked Response Test cleared by the FDA?
40-HZ Auditory Evoked Response Test (K862361) received a 510(k) decision of Substantially Equivalent on September 17, 1986, 86 days after the submission was received.
What is the product code of K862361?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.