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510(k) K895954

LARYNGOSTAT LARYNGOSCOPE HANDLE by Michigan Instruments, Inc. — Product Code CCW

K895954 is an FDA 510(k) premarket notification submitted by Michigan Instruments, Inc. for the device "LARYNGOSTAT LARYNGOSCOPE HANDLE". The FDA issued a decision of Substantially Equivalent on October 30, 1989. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Michigan Instruments, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1989
Date Received
October 11, 1989
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 Michigan Instruments, Inc.

  • K073079 — THUMPER, MODEL: 1008 (February 14, 2008)
  • K972525 — THUMPER (October 2, 1997)
  • K962237 — THUMPER CARDIOPULMONARY RESUSCITATOR (September 5, 1996)
  • K851139 — THUMPER CARDIOPULMONARY RESUSCITATOR 1005 (May 15, 1985)
  • K833879 — CARDIOPULMONARY RESUSCITATOR (December 27, 1983)
  • K811909 — CARDIOPULMUNARY RESUSCITATOR (July 16, 1981)

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)
  • K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (August 31, 2006)
  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K984101 — FLEXIBLADE (September 3, 1999)

FDA data resources