Cleared Traditional

D R Burton OxyPAP

K192000 · D R Burton Healthcare, LLC · Anesthesiology
Feb 2020
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K192000 is an FDA 510(k) clearance for the D R Burton OxyPAP, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by D R Burton Healthcare, LLC (Farmville, US). The FDA issued a Cleared decision on February 19, 2020, 208 days after receiving the submission on July 26, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K192000 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2019
Decision Date February 19, 2020
Days to Decision 208 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWF — Spirometer, Therapeutic (incentive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5690