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510(k) K945640

RI-SCOPE S OTOSCOPE by Rudolf Riester GmbH & Co. KG — Product Code HLJ

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 17, 1995
Date Received
November 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Rudolf Riester GmbH & Co. KG

  • K002954 — RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS (December 21, 2000)
  • K002955 — EMPIRE N BLOOD PRESSURE MANOMETERS (December 21, 2000)
  • K972377 — RI-MEGA (September 24, 1997)
  • K972378 — SANAPHON N (September 24, 1997)
  • K972379 — PRECISA N (September 24, 1997)
  • K972301 — BIG BEN SQUARE, BIG BEN ROUND (September 17, 1997)
  • K964338 — RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT (January 9, 1997)
  • 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)

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