Cleared Traditional

Pulmonary Function Tester, Model: A9

K231561 · Guangzhou Homesun Medical Technology Co., Ltd. · Anesthesiology

Feb 2024

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K231561 is an FDA 510(k) clearance for the Pulmonary Function Tester, Model: A9, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Guangzhou Homesun Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 21, 2024, 266 days after receiving the submission on May 31, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number	K231561 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2023
Decision Date	February 21, 2024
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF