The Keeler All Pupil Indirect Ophthalmoscope

• • Terminated Z-1132-2008 FDA Unclassified (pre-2012) ·initiated 8 Jan 2008

  Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.

510(k) Number

K854244 ↗

FDA Product Code

HLI

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Henson Cfa 3000 Central Visual Field Screener

  Class I

  FDA 510(k) K891610 Active Cleared 5 Jun 1989

• Keeler Tearscope-Plus

  Class II

  FDA 510(k) K973064 Active Cleared 7 Apr 1998

• Panoramic Loupes - Various

  Class II

  FDA 510(k) K841293 Active Cleared 9 May 1984

• Vickers Ergomatic Micros Instr-Long R or L Handed

  Class I

  FDA 510(k) K853180 Active Cleared 28 Oct 1985

• Henson - Hamblin Cfs 2000 Central Field Screen

  Class I

  FDA 510(k) K864467 Active Cleared 15 Dec 1986

• Spectacle Indirect Ophthalmoscope

  Class II

  FDA 510(k) K841292 Active Cleared 9 May 1984

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