FDA 510(k) Premarket Notification K243700: Apollo TMS Therapy System

Submission Details & Decision

Normalized public record details for 510(k) notification K243700.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K243700

Applicant / Sponsor

Mag & More GmbH

Device Name

Apollo TMS Therapy System

Product Code

OBP

Decision Date

2025-09-04

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Neurology (NE)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-11-29

Related Establishments / Registrations

MOLEX LLC Registration: 3003127839 View Registration
SPARTRONICS STRONGSVILLE, INC. Registration: 3003144120 View Registration
Neuronetics Inc. Registration: 3004824012 View Registration
RMF Design and Manufacturing Inc. Registration: 3005205657 View Registration
D&K Engineering, Inc. Registration: 3005268307 View Registration
TONICA ELEKTRONIK A/S Registration: 3005545216 View Registration
NEUROSOFT LTD Registration: 3006418479 View Registration
NEXSTIM PLC Registration: 3007147067 View Registration
TELEEMG, LLC Registration: 3008881376 View Registration
BRAINSWAY LTD. Registration: 3010300912 View Registration
MAGVENTURE A/S Registration: 3012352782 View Registration
MAG & MORE GMBH Registration: 3012823347 View Registration
BRAIN SCIENCE TOOLS BV Registration: 3014251656 View Registration
Domico Med-Device, LLC Registration: 3014680784 View Registration
Kuro Medical Registration: 3017496797 View Registration
MAGNUS MEDICAL INC. Registration: 3018708317 View Registration
REMED Co., Ltd. Registration: 3019055598 View Registration
MASTARS INDUSTRIES CO., LTD Registration: 3020848550 View Registration
MAKROMED, INC. Registration: 3029464335 View Registration
SHENZHEN YINGCHI TECHNOLOGY CO., LTD. Registration: 3029767018 View Registration
BTL Industries JSC Registration: 3035374386 View Registration
NEUROMODULATORY DEVICES & APPLICATIONS (NMDA), INC Registration: 3039167582 View Registration
THE MAGSTIM COMPANY LTD. Registration: 8021774 View Registration
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH Registration: 9612389 View Registration

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