Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pulmonary Function Tester, Model: A9

K-Number: K231561 · 2024-02-21

ApplicantGuangzhou Homesun Medical Technology Co., Ltd.
Decision Date2024-02-21
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pulmonary Function Tester, Model: A9 is a medical device manufactured by Guangzhou Homesun Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-21 under approval number K231561. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulmonary Function Tester, Model: A9?

Pulmonary Function Tester, Model: A9 is a medical device that received FDA 510(k) clearance on 2024-02-21. It is manufactured by Guangzhou Homesun Medical Technology Co., Ltd.. The 510(k) number is K231561.

When was Pulmonary Function Tester, Model: A9 approved by the FDA?

Pulmonary Function Tester, Model: A9 received FDA 510(k) clearance on 2024-02-21, under approval number K231561.

What company makes Pulmonary Function Tester, Model: A9?

Pulmonary Function Tester, Model: A9 is manufactured by Guangzhou Homesun Medical Technology Co., Ltd..

What is the FDA product code for Pulmonary Function Tester, Model: A9?

The FDA product code for Pulmonary Function Tester, Model: A9 is BTY.

Related Clinical Trials

NCT07610447 VR vs Treadmill Exercise in Children With Asthma RECRUITING NCT07608042 Lung Boost Therapy on Post-mastectomy Postmenopausal ENROLLING_BY_INVITATION NCT07603700 STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism NOT_YET_RECRUITING NCT07604961 Short-Term Inspiratory Muscle Training and Aerobic Exercise in Women With COPD COMPLETED NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40006408 Improving Fall Classification Accuracy of Multi-Input Models Using Three-Axis Accelerometer and Heart Rate Variability Data. Sensors (Basel, Switzerland) (2025)

Other Devices by Guangzhou Homesun Medical Technology Co., Ltd.

K191239Smart Peak Flow Meter

Related Devices (Code: BTY)

K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG K181912Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation K173937SpiroSphereEresearchtechnology GmbH K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsCosmed Srl K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑