IceCap product line— 510(k) K243788
Substantially EquivalentBioserenity Medical Devices Group
FDA 510(k) clearance K243788 for IceCap product line, Substantially Equivalent on 2025-03-13. Applicant: Bioserenity Medical Devices Group. Device class: 2.
Clearance details
- Applicant
- Bioserenity Medical Devices Group
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paris, FR
Recent devices under product code GXY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.