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510(k) K951337

FIBER HEAD LIGHT FH-300 by Neitz Instruments Company, Ltd. — Product Code HPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1995
Date Received
March 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headlamp, Operating, Ac-Powered
Device Class
Class II
Regulation Number
886.4335
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)
  • K950792 — STREAK RETINOSCOPE RX-3A (March 28, 1995)
  • K950789 — STREAK RETINOSCOPE RX-1 (March 28, 1995)
  • K950793 — SPOT RETINOSCOPE RX-3SP (March 28, 1995)
  • K950795 — STREAK RETINOSCOPE RX-RP (March 28, 1995)

Other clearances for product code HPQ

  • K952289 — WELCH ALLYN FIBER OPTIC HEADLIGNT (July 14, 1995)
  • K861747 — KEELER FIBEROPTIC HEADLAMP (August 21, 1986)
  • K861746 — KEELER DUAL LIGHTSOURCE (August 21, 1986)
  • K822272 — HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (November 10, 1982)