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Aio Hd Otoscope

by Blue Focus 510(k)

Active United States

510(k) K123821

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123821 Date17 May 2013ClearedStatusActive

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  • Withdrawn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
ERA
Device Class
Class I
Regulation
21 CFR Part 874.4770
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent