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510(k) K945425

MCINTOSH, MILLER, FOREGGER BABY by Rudolf Riester GmbH & Co. KG — Product Code CCW

K945425 is an FDA 510(k) premarket notification submitted by Rudolf Riester GmbH & Co. KG for the device "MCINTOSH, MILLER, FOREGGER BABY". The FDA issued a decision of Substantially Equivalent on March 20, 1995. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Rudolf Riester GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1995
Date Received
November 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Rigid
Device Class
Class I
Regulation Number
868.5540
Review Panel
AN
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 CCW

  • K191602 — APA Oxy Blade (August 2, 2019)
  • K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (June 22, 2017)
  • K140951 — YEESCOPE LARYNGOSCOPES (November 10, 2014)
  • K121378 — AIRTRAQ SP AIRTRAQ AVANT (June 21, 2012)
  • K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (February 9, 2007)
  • K062523 — TRU-MR LARYNGOSCOPE SET (November 17, 2006)
  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K984101 — FLEXIBLADE (September 3, 1999)

FDA data resources