FDA 510(k)

Portable Scalp Cooling System

Номер K: K211526 · 2021-10-21

Дата решения2021-10-21

Код продуктаPMC

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Portable Scalp Cooling System is the device name listed in this FDA 510(k) record. The listed applicant is Cooler Heads Care, Inc.. It received FDA 510(k) clearance on 2021-10-21 under 510(k) number K211526. 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 Portable Scalp Cooling System?

Portable Scalp Cooling System is a medical device that received FDA 510(k) clearance on 2021-10-21. The listed applicant is Cooler Heads Care, Inc.. The 510(k) number is K211526.

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

Portable Scalp Cooling System received FDA 510(k) clearance on 2021-10-21, under 510(k) number K211526.

Who is the listed applicant for Portable Scalp Cooling System?

The FDA 510(k) record lists Cooler Heads Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Portable 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: PMC)

K252289Eva Scalp Cooling SystemStemtech Medical Devices Private Limited K191166DigniCap DeltaDignitana, Inc.K173032Paxman Scalp CoolerPaxman Coolers Limited K170871DigniCap Scalp Cooling SystemDignitana AB K163484Paxman Scalp CoolerPaxman Coolers Limited

Официальный источник

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