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510(k) K945507

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

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

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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)
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Other clearances for product code KZF

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  • 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)