Precision Flow® HVNI— 510(k) DEN170001

Name: FDA 510(k) clearance DEN170001
Creator: U.S. Food and Drug Administration
Published: 2018-04-10

Unknown

Vapotherm, Inc.

FDA 510(k) clearance DEN170001 for Precision Flow® HVNI, Unknown on 2018-04-10. Applicant: Vapotherm, Inc.. Device class: 2.

Clearance details

Applicant: Vapotherm, Inc.
Product code: Code QAV
Device class: Class 2
Regulation: 21 CFR 868.5454
Advisory panel: Anesthesiology
Date received: 2017-01-03
Decision date: 2018-04-10
Decision: Unknown
Clearance type: Direct
Location: Exeter, NH, US

View on FDA.gov ↗

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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.