Computer Interface - Biofeedback

FDA 510(k) K850759 · M.O.E Electronics Research & Prod.

Substantially Equivalent

510(k) numberK850759

Submission

Device name
Computer Interface - Biofeedback
Applicant
M.O.E Electronics Research & Prod.
Santa Cruz, CA, US
Received
February 25, 1985
Decision date
May 23, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was Computer Interface - Biofeedback cleared by the FDA?

Computer Interface - Biofeedback (K850759) received a 510(k) decision of Substantially Equivalent on May 23, 1985, 87 days after the submission was received.

What is the product code of K850759?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.