510(k) K221318

Device

HVT 2.0

Applicant

Vapotherm, Inc.

510(k) number

K221318

Product code

QAV

Decision

Substantially Equivalent (SESE)

Decision date

2022-12-13

Date received

2022-05-06

Regulation

868.5454

Classification name

High Flow/High Velocity Humidified Oxygen Delivery Device

Medical specialty

Anesthesiology

Review panel

Anesthesiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No