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510(k) K013089

EMS HEPA FILTER AND HME COMBINATIONS by Engineered Medical Systems — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2002
Date Received
September 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Engineered Medical Systems

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  • 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)
  • 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 CAH

  • K241339 — Besmed Bacterial Filter and HMEF (November 14, 2024)
  • K222917 — Breathing circuit bacterial/viral filter (February 15, 2024)
  • K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (September 16, 2023)
  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K221472 — Filter and HME/Filter (February 8, 2023)
  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
  • K221250 — EasyOne Filter (November 22, 2022)
  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)
  • K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (November 16, 2021)
  • K202459 — Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-H (September 26, 2021)