FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K Number: K234080
·
Decision Mar 25, 2024
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
6
Review Days
94
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Basic Information
- Device Name
- MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
- K Number
- K234080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Soterix Medical, Inc.
- Date Received
- December 22, 2023
- Decision Date
- March 25, 2024
- Product Code
- GWF
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Soterix Medical, Inc.
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|---|---|---|---|
| K251653 | SPRY TMS Therapy System (0550) | Feb 20, 2026 | Substantially Equivalent |
| K233751 | Milieve (YPS-301BD) | Jun 3, 2024 | Substantially Equivalent |
| K192823 | MEGA-TMS | Aug 13, 2021 | Substantially Equivalent |
| K191422 | Neural Navigator | Apr 6, 2020 | Substantially Equivalent |
| K170291 | IontoDC | May 1, 2017 | Substantially Equivalent |