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510(k) K964338

RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT by Rudolf Riester GmbH & Co. KG — Product Code HKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1997
Date Received
October 31, 1996
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

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  • K972379 — PRECISA N (September 24, 1997)
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  • K950914 — RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAEST (July 24, 1995)
  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K945541 — SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE (May 8, 1995)
  • K945425 — MCINTOSH, MILLER, FOREGGER BABY (March 20, 1995)

Other clearances for product code HKM

  • K950792 — STREAK RETINOSCOPE RX-3A (March 28, 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)
  • K950791 — STREAK RETINOSCOPE RX-3 (March 28, 1995)
  • K840840 — GENERATED RETINAL REFLEX IMAGERY SYS (July 12, 1984)