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FDA 510(k)

可攜式頭部冷卻系統

K 號：K211526 · 2021-10-21

申請人Cooler Heads Care, Inc.
決定日期2021-10-21
產品代碼PMC
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：PMC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252289Eva頭部冷卻系統Stemtech Medical Devices Private LimitedK191166DigniCap DeltaDignitana, Inc.K173032Paxman 頭部冷卻器Paxman Coolers LimitedK170871DigniCap 頭部冷卻系統Dignitana ABK163484Paxman 頭部冷卻器Paxman Coolers Limited

官方來源

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