Cleared Traditional

Air Smart Extra Spirometer

K222443 · Feellife Health, Inc. · Anesthesiology
Aug 2023
Decision
362d
Days
Class 2
Risk

About This 510(k) Submission

K222443 is an FDA 510(k) clearance for the Air Smart Extra Spirometer, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Feellife Health, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on August 9, 2023, 362 days after receiving the submission on August 12, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K222443 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2022
Decision Date August 09, 2023
Days to Decision 362 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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