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510(k) K972440

CATARACTSCREENER CT - S by Neitz Instruments Company, Ltd. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1997
Date Received
June 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Neitz Instruments Company, Ltd.

  • K951341 — NEITZ SLIT LAMP SL-H2 (June 15, 1995)
  • K951337 — FIBER HEAD LIGHT FH-300 (June 8, 1995)
  • 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)
  • K950789 — STREAK RETINOSCOPE RX-1 (March 28, 1995)
  • K950795 — STREAK RETINOSCOPE RX-RP (March 28, 1995)
  • K950794 — STREAK RETINOSCOPE RX-RC (March 28, 1995)
  • K950792 — STREAK RETINOSCOPE RX-3A (March 28, 1995)
  • K950793 — SPOT RETINOSCOPE RX-3SP (March 28, 1995)

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