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510(k) K842128

AMERICAN MEDICAL OPTICS PHOTOKERATO by American Medical Optics — Product Code HJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1984
Date Received
May 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photokeratoscope
Device Class
Class I
Regulation Number
886.1350
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)
  • K851263 — AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP (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)

Other clearances for product code HJA

  • K901523 — VKG 1000, VIDEO KERATOGRAPH (June 27, 1990)
  • K893968 — VKG 2000 VIDEO KERATOMETER (September 11, 1989)
  • K830290 — DORC CONTACT/PHOTO DERATOSCOPE (March 9, 1983)
  • K781650 — TERRY KERATOMETER (October 17, 1978)