FDA 510(k) Premarket Notification K792659: FEEDBACK EDR SYSTEM MODEL ME-1

Submission Details & Decision

Normalized public record details for 510(k) notification K792659.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K792659

Applicant / Sponsor

Bio-Feedback Systems, Inc.

Device Name

FEEDBACK EDR SYSTEM MODEL ME-1

Product Code

HCC

Decision Date

1980-01-09

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Neurology (NE)

Clearance Type

Traditional

Third Party Flag

Date Received

1979-12-26

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