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510(k) K220533

Endoscopy Oxygen Mask by Engineered Medical Systems, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2022
Date Received
February 24, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Engineered Medical Systems, Inc.

  • K062104 — TALKING TRACH (April 20, 2007)
  • K023683 — MULTI-STRAP FULL FACE MASK (December 1, 2003)
  • K013728 — TRACH VOX (July 30, 2002)
  • 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 CCK

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  • K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO (June 4, 2025)
  • K240937 — AIM (N/A) (December 16, 2024)
  • K230915 — AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (November 12, 2024)
  • K212425 — MicroTrend System (November 7, 2024)
  • K222511 — Oxy2Pro (November 21, 2023)
  • K213767 — Endure ETCO2/02 Nasal Cannula (September 12, 2023)
  • K221118 — CO2 Mainstream Sensor (April 5, 2023)
  • K210112 — XChange Device, XChange System (January 30, 2023)