FDA 510(k)

イヴ Scalp クールイングシステム

K番号: K252289 · 2025-11-25

申請者Stemtech Medical Devices Private Limited

決定日2025-11-25

製品コードPMC

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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イヴ Scalp クールイングシステム

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：PMC）

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