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510(k) K945507

H 5100, H 5200, H 5300 by Rudolf Riester GmbH & Co. KG — Product Code KZF

K945507 is an FDA 510(k) premarket notification submitted by Rudolf Riester GmbH & Co. KG for the device "H 5100, H 5200, H 5300". The FDA issued a decision of Substantially Equivalent on December 9, 1994. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. Rudolf Riester GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1994
Date Received
November 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Medical Examination, Ac Powered
Device Class
Class I
Regulation Number
880.6320
Review Panel
HO
Submission Type

Other clearances by Rudolf Riester GmbH & Co. KG

  • K002955 — EMPIRE N BLOOD PRESSURE MANOMETERS (December 21, 2000)
  • K002954 — RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS (December 21, 2000)
  • K972377 — RI-MEGA (September 24, 1997)
  • K972379 — PRECISA N (September 24, 1997)
  • K972378 — SANAPHON 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)

Other clearances for product code KZF

  • K954943 — NEVOSCOPE (March 27, 1996)
  • K952835 — WELCH ALLYN VIDEO EPISCOPE (September 22, 1995)
  • K941869 — SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG (August 3, 1994)
  • K936088 — WAVE FLUORESCENT MAGNIFIER (April 26, 1994)
  • K940284 — MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION (February 28, 1994)
  • K933564 — SKYTRON EXAM LIGHT (February 10, 1994)
  • K935832 — CHROMOPHARE (February 3, 1994)
  • K934259 — AC-POWERED MEDICAL EXAMINATION LIGHT (January 28, 1994)
  • K932719 — RITTER MODEL 158 AND 159 EXAM LIGHTS (December 2, 1993)
  • K924447 — VITAPEN (September 27, 1993)

FDA data resources