Shenzhen Witleaf Medical Electronics Co., Ltd. FDA Approvals

0 new drug approvals and 2 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
Handheld Pulse Oximeter510(k)Feb 26, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 26, 2023
Fingertip Pulse Oximeter510(k)Dec 30, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 30, 2022