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510(k) K942715

NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC by Neitz Instruments Company, Ltd. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
June 9, 1994
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 Neitz Instruments Company, Ltd.

  • K972440 — CATARACTSCREENER CT - S (September 30, 1997)
  • 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)
  • K950794 — STREAK RETINOSCOPE RX-RC (March 28, 1995)
  • K950789 — STREAK RETINOSCOPE RX-1 (March 28, 1995)
  • K950795 — STREAK RETINOSCOPE RX-RP (March 28, 1995)
  • K950792 — STREAK RETINOSCOPE RX-3A (March 28, 1995)

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