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510(k) K950789

STREAK RETINOSCOPE RX-1 by Neitz Instruments Company, Ltd. — Product Code HKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1995
Date Received
February 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retinoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1780
Review Panel
OP
Submission Type

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  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951340 — NEITZ SLIT LAMP SL-H1 (April 10, 1995)
  • K951338 — INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV (April 7, 1995)
  • K950794 — STREAK RETINOSCOPE RX-RC (March 28, 1995)
  • K950795 — STREAK RETINOSCOPE RX-RP (March 28, 1995)
  • K950793 — SPOT RETINOSCOPE RX-3SP (March 28, 1995)
  • K950792 — STREAK RETINOSCOPE RX-3A (March 28, 1995)

Other clearances for product code HKL

  • K001111 — PANORET, MODEL 1000A (July 7, 2000)
  • K950790 — STREAK RETINOSCOPE RX-2 (March 22, 1995)
  • K893171 — VISTA STREAK RETINOSCOPE (AC-POWERED) (September 21, 1989)
  • K812764 — KOI BLUE FIELD ENTOPTOSCOPE (December 2, 1981)
  • K800238 — MOIRE FRINGE VISOMETER AFTER LOTMAR (March 10, 1980)