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510(k) K042245

VAPOTHERM MODEL#2000I, 200H by Vapotherm, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2004
Date Received
August 19, 2004
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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  • 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)
  • K013486 — VAPOTHERM 2000H (May 30, 2003)

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