FDA 510(k)

Eva Scalp Cooling System

Номер K: K252289 · 2025-11-25

ЗаявительStemtech Medical Devices Private Limited

Дата решения2025-11-25

Код продуктаPMC

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Eva Scalp Cooling System is the device name listed in this FDA 510(k) record. The listed applicant is Stemtech Medical Devices Private Limited. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K252289. The device is classified under product code PMC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Eva Scalp Cooling System?

Eva Scalp Cooling System is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Stemtech Medical Devices Private Limited. The 510(k) number is K252289.

When did Eva Scalp Cooling System receive FDA 510(k) clearance?

Eva Scalp Cooling System received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252289.

Who is the listed applicant for Eva Scalp Cooling System?

The FDA 510(k) record lists Stemtech Medical Devices Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eva Scalp Cooling System?

The FDA product code for Eva Scalp Cooling System is PMC.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: PMC)

K211526Portable Scalp Cooling SystemCooler Heads Care, Inc.K191166DigniCap DeltaDignitana, Inc.K173032Paxman Scalp CoolerPaxman Coolers Limited K170871DigniCap Scalp Cooling SystemDignitana AB K163484Paxman Scalp CoolerPaxman Coolers Limited

Официальный источник

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