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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K202171

Pulmogine Vibrating Mesh Nebulizer · Hcmed Innovations Co., Ltd. · decided 2021-07-01 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Aerogen® Go 04EE12000012HCMED INNOVATIONS CO., LTD.CAF04719873130214
Aerogen® Go 00USA86C0004HCMED INNOVATIONS CO., LTD.CAF04719873130351
Aerogen® Go 00USA86C0005HCMED INNOVATIONS CO., LTD.CAF04719873130207