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510(k) K221250

EasyOne Filter by Ndd Medizintechnik AG — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2022
Date Received
May 2, 2022
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 Ndd Medizintechnik AG

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  • K161534 — EasyOne Pro Respiratory Analysis System (February 22, 2017)
  • K161536 — EasyOne Air Spirometer (January 5, 2017)

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  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 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)
  • K191909 — HepaShield Bacterial Viral Breathing System Filter (March 23, 2020)