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60 Fundus Camera Cf-60UV

by Canon USA, Inc. 510(k)

Active United States

510(k) K946058

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK946058 Date3 Feb 1995ClearedStatusActive

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  • Withdrawn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
HKI
Device Class
Class II
Regulation
21 CFR Part 886.1120
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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