Cleared Traditional

Breathe+

K222018 · Peep Medical, LLC Dba Go2 Devices · Anesthesiology
Jun 2023
Decision
329d
Days
Class 2
Risk

About This 510(k) Submission

K222018 is an FDA 510(k) clearance for the Breathe+, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Peep Medical, LLC Dba Go2 Devices (Houston, US). The FDA issued a Cleared decision on June 2, 2023, 329 days after receiving the submission on July 8, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K222018 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2022
Decision Date June 02, 2023
Days to Decision 329 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