Cleared Traditional

TD-7301 Spirometer (TD-7301)

K241843 · Gostar Co., Ltd. · Anesthesiology
Nov 2024
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K241843 is an FDA 510(k) clearance for the TD-7301 Spirometer (TD-7301), a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Gostar Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on November 20, 2024, 147 days after receiving the submission on June 26, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K241843 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2024
Decision Date November 20, 2024
Days to Decision 147 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