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510(k) K141087

INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF by Intersurgical Incorporated — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2015
Date Received
April 28, 2014
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 Intersurgical Incorporated

  • K132143 — EXHALATION VALVE (June 4, 2014)
  • K121747 — FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS (March 14, 2013)

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  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
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  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)
  • K211286 — Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (November 16, 2021)
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