Epison, Alerting System for Epileptics
FDA 510(k) K862766 · Zygo Industries, Inc.
510(k) numberK862766
Submission
- Device name
- Epison, Alerting System for Epileptics
- Applicant
- Zygo Industries, Inc.
Portland, OR, US - Received
- July 22, 1986
- Decision date
- March 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Epison, Alerting System for Epileptics cleared by the FDA?
Epison, Alerting System for Epileptics (K862766) received a 510(k) decision of Substantially Equivalent on March 13, 1987, 234 days after the submission was received.
What is the product code of K862766?
The FDA product code is LEL – Device, Sleep Assessment, a Class II (moderate risk) device regulated under 21 CFR 882.5050.