510(k) K200848

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit by Micron Medical Corporation — Product Code GZF

K200848 is an FDA 510(k) premarket notification submitted by Micron Medical Corporation for the device "Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit". The FDA issued a decision of Substantially Equivalent on August 14, 2020. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870.