510(k) Report

Devices descending from DEN180041

4 later devices reach Monarch eTNS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232991BT-1000Bistos Co., Ltd.20240—
+1K233293Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®Neurosigma, Inc.20240—
+1K213629SMILENu Eyne Co., Ltd.20231—
+2K243289Addnox (BPSPM1)Nu Eyne Co., Ltd.20250—