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Ta-641 Tinnitus Instrument

by Audiotrone 510(k)

Active United States

510(k) K800702

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800702 Date8 May 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KLW
Device Class
Class II
Regulation
21 CFR Part 874.3400
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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