Home / 510(k) Clearances / K013728

510(k) K013728

TRACH VOX by Engineered Medical Systems — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2002
Date Received
November 9, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Engineered Medical Systems

  • K220533 — Endoscopy Oxygen Mask (November 16, 2022)
  • K062104 — TALKING TRACH (April 20, 2007)
  • K023683 — MULTI-STRAP FULL FACE MASK (December 1, 2003)
  • K013122 — EMS ELECTROSTATIC FLITER AND HME COMBINATION (April 19, 2002)
  • K013123 — EMS PULMONARY FUNCTION TESTING FILTER (March 14, 2002)
  • K013089 — EMS HEPA FILTER AND HME COMBINATIONS (March 14, 2002)
  • K003497 — DISPOSABLE PRESSURE MONITOR (November 30, 2000)
  • K000215 — SWIVEL ELBOW (May 26, 2000)
  • K000314 — INCENTIVE SPIROMETER (April 12, 2000)
  • K991955 — MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH C (July 6, 1999)

Other clearances for product code JOH

  • K251313 — Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with (December 29, 2025)
  • K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach (November 26, 2021)
  • K203362 — TRACOE vario (August 5, 2021)
  • K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (June 1, 2020)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube (March 22, 2019)
  • K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc (May 8, 2018)
  • K180034 — Weinmann Tracheostomy Exchange Set (May 7, 2018)
  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
  • K170720 — Portex Blue Line Ultra Paediatric Tracheosomy Tube (December 7, 2017)