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510(k) K000401

VAPOTHERM, MODEL 2000I by Vapotherm, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2000
Date Received
February 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Vapotherm, Inc.

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  • K203357 — HVT 2.0 (August 25, 2021)
  • K191010 — Palladium High Flow Therapy System (October 10, 2019)
  • DEN170001 — Precision Flow® HVNI (April 10, 2018)
  • K111640 — PRECISION FLOW(R) - HELIOX (October 7, 2011)
  • K103316 — FLOWREST (February 8, 2011)
  • K072845 — PRECISION FLOW (July 17, 2008)
  • K070056 — VAPOTHERM MODEL# 2000I AND 2000H (April 13, 2007)
  • K042245 — VAPOTHERM MODEL#2000I, 200H (August 30, 2004)

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  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
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