HVT 2.0— 510(k) K221318

Substantially Equivalent

Vapotherm, Inc.

FDA 510(k) clearance K221318 for HVT 2.0, Substantially Equivalent on 2022-12-13. Applicant: Vapotherm, Inc..

Clearance details

Applicant: Vapotherm, Inc.
Product code: Code QAV
Advisory panel: Anesthesiology
Date received: 2022-05-06
Decision date: 2022-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exeter, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QAV

product code QAV

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.