FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Milieve (YPS-301BD)
K Number: K233751
·
Decision Jun 3, 2024
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
17
Applicant Total
6
Review Days
194
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Basic Information
- Device Name
- Milieve (YPS-301BD)
- K Number
- K233751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5891
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Soterix Medical, Inc.
- Date Received
- November 22, 2023
- Decision Date
- June 3, 2024
- Product Code
- PCC
- 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 |
|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | FDA class 2 | Neurology |
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Other Clearances by Soterix Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251653 | SPRY TMS Therapy System (0550) | Feb 20, 2026 | Substantially Equivalent |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Mar 25, 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 |