Cleared Traditional

Alveoair Digital Spirometer

K222525 · Roundworks Technologies Private Limited · Anesthesiology
Aug 2023
Decision
371d
Days
Class 2
Risk

About This 510(k) Submission

K222525 is an FDA 510(k) clearance for the Alveoair Digital Spirometer, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Roundworks Technologies Private Limited (Wakad, Pune, IN). The FDA issued a Cleared decision on August 28, 2023, 371 days after receiving the submission on August 22, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K222525 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2022
Decision Date August 28, 2023
Days to Decision 371 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840