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FDA 510(k) Applications Submitted by Soterix Medical, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K191422
05/29/2019
Neural Navigator
Soterix Medical, Inc.
K192823
10/02/2019
MEGA-TMS
Soterix Medical, Inc.
K233751
11/22/2023
Milieve (YPS-301BD)
Soterix Medical, Inc.
K234080
12/22/2023
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
Soterix Medical, Inc.
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