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510(k) K851263

AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP by American Medical Optics — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1985
Date Received
March 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by American Medical Optics

  • K860001 — BARRAQUER-KRUMEICH REFRACTIVE SET (February 4, 1986)
  • K851264 — AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS (May 1, 1985)
  • K851262 — AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA (April 30, 1985)
  • K844150 — MEDICAL OPTICS PHACOEMULSIFICATION KIT (December 11, 1984)
  • K843966 — ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS (November 8, 1984)
  • K843965 — ARGON LASER PHOTOCOAGULATOR SYS (November 6, 1984)
  • K842504 — AMER. MEDICAL OPTICS DIGITAL KERATO- (October 1, 1984)
  • K842197 — AMERICAN MEDICAL OPTICS I/A KIT- IRRIG (October 1, 1984)
  • K842127 — AMERICAN MEDICAL OPTICS IMAGING SYS (September 7, 1984)
  • K842251 — AMERI. MEDICAL OPTICS ARGON LASER PHOTO (August 15, 1984)

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