EEG Biofeedback Device Accessory

FDA 510(k) K842021 · Electronics Research & Production

Substantially Equivalent

510(k) numberK842021

Submission

Device name
EEG Biofeedback Device Accessory
Applicant
Electronics Research & Production
Mchenry, IL, US
Received
May 18, 1984
Decision date
July 20, 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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More from Medotech A/S

510(k)DeviceDecision
K842023Temp. & GSR Biofeedback DeviceHCC · Traditional 07/20/1984SE
K842022EEG Biofeedback DeviceHCC · Traditional 07/20/1984SE

Questions and answers

When was EEG Biofeedback Device Accessory cleared by the FDA?

EEG Biofeedback Device Accessory (K842021) received a 510(k) decision of Substantially Equivalent on July 20, 1984, 63 days after the submission was received.

What is the product code of K842021?

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