PROVENT PROFESSIONAL SLEEP APNEA THERAPY— 510(k) K090398

Name: FDA 510(k) clearance K090398
Creator: U.S. Food and Drug Administration
Published: 2009-04-03

Substantially Equivalent

Ventus Medical, Inc.

FDA 510(k) clearance K090398 for PROVENT PROFESSIONAL SLEEP APNEA THERAPY, Substantially Equivalent on 2009-04-03. Applicant: Ventus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Ventus Medical, Inc.
Product code: Code OHP
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2009-02-17
Decision date: 2009-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belmont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OHP

view all

K191728 — ULTepap Expiratory Positive Airway Pressure (EPAP) Device2020-02-21
K180619 — Bongo2018-08-16
K102404 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)2010-12-02
K071560 — PROVENT NASAL DILATOR, MODEL BR22008-02-08

More clearances from Ventus Medical, Inc.

view all

K120665 — INVENT SNORING DEVICE2012-06-12
K080983 — PROVENT NASAL CANNULA2008-08-07

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