Shenzhen Imdk Medical Technology Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)510(k)May 11, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 11, 2026
Wrist Blood Pressure Monitor (BPM-W1VL)510(k)Feb 13, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 13, 2026
Arm Blood Pressure Monitor (model: BPM-A7VL)510(k)Nov 26, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 26, 2024
EMS/TENS Massager Device510(k)Feb 12, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 12, 2024
Pulse Oximeter (Model C101A2, C101B1, C101A3)510(k)Oct 16, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Oct 16, 2022