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510(k) K950795

STREAK RETINOSCOPE RX-RP by Neitz Instruments Company, Ltd. — Product Code HKM

K950795 is an FDA 510(k) premarket notification submitted by Neitz Instruments Company, Ltd. for the device "STREAK RETINOSCOPE RX-RP". The FDA issued a decision of Substantially Equivalent on March 28, 1995. The device falls under product code HKM (Retinoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1780. Neitz Instruments Company, Ltd. has at least 10 other 510(k) clearances on record.

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, Battery-Powered
Device Class
Class I
Regulation Number
886.1780
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)
  • K950791 — STREAK RETINOSCOPE RX-3 (March 28, 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)

Other clearances for product code HKM

  • K964338 — RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT (January 9, 1997)
  • K950794 — STREAK RETINOSCOPE RX-RC (March 28, 1995)
  • K950791 — STREAK RETINOSCOPE RX-3 (March 28, 1995)
  • K950792 — STREAK RETINOSCOPE RX-3A (March 28, 1995)
  • K950793 — SPOT RETINOSCOPE RX-3SP (March 28, 1995)
  • K840840 — GENERATED RETINAL REFLEX IMAGERY SYS (July 12, 1984)

FDA data resources