FDA 510(k)

Portable Scalp Cooling System

Número K: K211526 · 2021-10-21

Data da decisão2021-10-21

Código do produtoPMC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Dispositivos Relacionados (Código: 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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.