Cleared Traditional

O-PEP

K150044 · Pari Respiratory Equipment, Inc. · Anesthesiology
May 2016
Decision
501d
Days
Class 2
Risk

About This 510(k) Submission

K150044 is an FDA 510(k) clearance for the O-PEP, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on May 27, 2016, 501 days after receiving the submission on January 12, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K150044 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2015
Decision Date May 27, 2016
Days to Decision 501 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