FDA Device Entity Profile: Neuronetics Inc

Known Identifiers & Locations

FEI Numbers 3004824012

Owner Operator Numbers 10027686

Locations Covered Malvern, PA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3004824012	Neuronetics Inc.	Malvern, PA, US	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K231926	NeuroStar Advanced Therapy System (All previously cleared models)	2024-03-22	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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