Biocomp 2001 Biofeedback Device

FDA 510(k) K872495 · Biofeedback Research Institute, Inc.

Substantially Equivalent

510(k) numberK872495

Submission

Device name
Biocomp 2001 Biofeedback Device
Applicant
Biofeedback Research Institute, Inc.
Los Angeles, CA, US
Received
June 24, 1987
Decision date
August 4, 1987
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 Biocomp 2001 Biofeedback Device cleared by the FDA?

Biocomp 2001 Biofeedback Device (K872495) received a 510(k) decision of Substantially Equivalent on August 4, 1987, 41 days after the submission was received.

What is the product code of K872495?

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