Qingdao Hisense Medical Equipment Co., Ltd. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
HD80 Series Ultrasound Diagnostic System510(k)May 16, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 16, 2024
HD60 Series Ultrasound Diagnostic System510(k)Feb 21, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 21, 2024
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D510(k)Nov 17, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 17, 2022
Hisense LCD monitor HMD2G21S, HMD3G21S510(k)Nov 8, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 8, 2022
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)510(k)Jul 26, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 26, 2022
HD60 Series Ultrasound Diagnostic System510(k)Jun 8, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 8, 2022