CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105

FDA 510(k)

FDA Class 2 ·Anesthesiology

HRS Co.,Ltd

Manufacturer

🇰🇷 South Korea

Paonan Biotech Co., Ltd.

Manufacturer

🇹🇼 Taiwan

WON TECH Co., Ltd

Manufacturer

🇰🇷 South Korea

Bio-Molecular Systems Pty Ltd

Manufacturer

🇦🇺 Australia·2 Importers

Zeev Implants Ltd.

Manufacturer

🇮🇱 Israel

Beacon Medical LLC

Manufacturer

🇺🇸 United States·1 Importer

Chensin Packing Industry Co. Ltd

Manufacturer

🇹🇼 Taiwan

Novamedic Co.,Ltd.

Manufacturer

🇹🇭 Thailand·1 Basic UDI-DI·4 Devices

Eyelove Corp Ltd.

Manufacturer

🇹🇼 Taiwan

Rad Source Technologies Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

Leadgene Biomedical, Inc.

Manufacturer

🇹🇼 Taiwan

Infinite Biomedical Technologies LLC

Manufacturer

🇺🇸 United States·4 Importers

J Summit Co., Ltd.

Manufacturer

🇹🇭 Thailand

Trice Medical

Manufacturer

🇺🇸 United States·1 Importer

Ethos Evacuation Strategies, LLC

Manufacturer

🇺🇸 United States

MPI Inc.

Manufacturer

🇯🇵 Japan

Cagent Vascular, Inc.

Manufacturer

🇺🇸 United States·1 Importer

SINAPI Biomedical (Pty) Ltd

Manufacturer

🇿🇦 South Africa·4 Importers

YTY INDUSTRY SDN BHD

Manufacturer

🇲🇾 Malaysia·1 Basic UDI-DI·44 Devices·1 Importer