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CAB2 Computer Assisted Biofeedback

by Discrete Data Systems, Inc. 510(k)

Active United States

510(k) K843738

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843738 Date4 Dec 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HCC
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent