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510(k) K946043

H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG by Rudolf Riester GmbH & Co. KG — Product Code ERA

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 8, 1995
Date Received
December 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
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)

Other clearances for product code ERA

  • K123821 — AIO HD OTOSCOPE (May 17, 2013)
  • K121326 — LANTOS 3D EAR SCANNER (January 25, 2013)
  • K110326 — OSRAM ITOS (October 27, 2011)
  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K955043 — WELCH ALLYN BI-OTOSCOPE (November 14, 1995)
  • K952578 — WELCH ALLY OTOSCOPE (July 10, 1995)
  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)