The following data is part of a premarket notification filed by Neuronetics, Inc. with the FDA for Neurostar Tms Therapy System.
Device ID | K161519 |
510k Number | K161519 |
Device Name: | NeuroStar TMS Therapy System |
Classification | Transcranial Magnetic Stimulator |
Applicant | NEURONETICS, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355 |
Contact | Judy P. Ways |
Correspondent | Judy P. Ways NEURONETICS, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355 |
Product Code | OBP |
CFR Regulation Number | 882.5805 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-02 |
Decision Date | 2016-09-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850005944232 | K161519 | 000 |
10850005944215 | K161519 | 000 |
00850005944652 | K161519 | 000 |