Eva Scalp Cooling System— 510(k) K252289
Substantially EquivalentStemtech Medical Devices Private Limited
FDA 510(k) clearance K252289 for Eva Scalp Cooling System, Substantially Equivalent on 2025-11-25. Applicant: Stemtech Medical Devices Private Limited. Device class: 2.
Clearance details
- Applicant
- Stemtech Medical Devices Private Limited
- Product code
- Code PMC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4360
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Navi Mumbai, IN
Recent devices under product code PMC
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