Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HVT 2.0

K-Number: K221318 · 2022-12-13

ApplicantVapotherm, Inc.
Decision Date2022-12-13
Product CodeQAV
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HVT 2.0 is a medical device manufactured by Vapotherm, Inc.. It received FDA 510(k) clearance on 2022-12-13 under approval number K221318. The device is classified under product code QAV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HVT 2.0?

HVT 2.0 is a medical device that received FDA 510(k) clearance on 2022-12-13. It is manufactured by Vapotherm, Inc.. The 510(k) number is K221318.

When was HVT 2.0 approved by the FDA?

HVT 2.0 received FDA 510(k) clearance on 2022-12-13, under approval number K221318.

What company makes HVT 2.0?

HVT 2.0 is manufactured by Vapotherm, Inc..

What is the FDA product code for HVT 2.0?

The FDA product code for HVT 2.0 is QAV.

Other Devices by Vapotherm, Inc.

DEN170001Precision Flow® HVNI K191010Palladium High Flow Therapy System K203357HVT 2.0 K220869Vapotherm Aerosol Adapter AAA-2 K254078HVT 2.0

Related Devices (Code: QAV)

DEN170001Precision Flow® HVNIVapotherm, Inc. K221338F&P Airvo 3Fisher & Paykel Healthcare

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑