CAB2 Computer Assisted Biofeedback

FDA 510(k) K843738 · Discrete Data Systems, Inc.

Substantially Equivalent

510(k) numberK843738

Submission

Device name
CAB2 Computer Assisted Biofeedback
Applicant
Discrete Data Systems, Inc.
La Jolla, CA, US
Received
September 25, 1984
Decision date
December 4, 1984
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 CAB2 Computer Assisted Biofeedback cleared by the FDA?

CAB2 Computer Assisted Biofeedback (K843738) received a 510(k) decision of Substantially Equivalent on December 4, 1984, 70 days after the submission was received.

What is the product code of K843738?

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