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510(k) K971348

FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM by Green Field Medical Sourcing, Inc. — Product Code CAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1998
Date Received
April 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Esophageal (Obturator)
Device Class
Class II
Regulation Number
868.5650
Review Panel
AN
Submission Type

Other clearances by Green Field Medical Sourcing, Inc.

  • K971759 — MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER (March 2, 1998)
  • K954150 — VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) (December 20, 1995)
  • K944667 — LIFE PULSE TESUSCITATION TIMER (October 4, 1994)
  • K932867 — LIFE PULSE RESUSCITATION TIMER (July 25, 1994)

Other clearances for product code CAO

  • K894032 — EVAC-TUBE (August 31, 1989)
  • K875226 — ESOPHAGEAL OBTURATOR/TRACHEAL TUBE (January 19, 1988)
  • K864200 — VETA/VENTED ESOPHAGEAL TUBE AIRWAY (March 17, 1987)
  • K863172 — RESPIRONICS PTL REVIVEEASY (November 4, 1986)
  • K761195 — ESOPHAGEAL OBTURATION AIRWAY (December 9, 1976)