• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name high flow/high velocity humidified oxygen delivery device
510(k) Number K221318
Device Name HVT 2.0
Vapotherm Inc.
100 Domain Drive
Exeter,  NH  03833
Applicant Contact Michael J. Webb
Vapotherm Inc.
100 Domain Drive
Exeter,  NH  03833
Correspondent Contact Michael J. Webb
Regulation Number868.5454
Classification Product Code
Date Received05/06/2022
Decision Date 12/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No