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510(k) K070056

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2007
Date Received
January 5, 2007
Clearance Type
Special
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)
  • K042245 — VAPOTHERM MODEL#2000I, 200H (August 30, 2004)
  • K013486 — VAPOTHERM 2000H (May 30, 2003)

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