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FDA 510(k)

prolaio eVO2peak 模組（版本 1.0）

K 號：K252204 · 2025-12-16

申請人Prolaio, Inc.
決定日期2025-12-16
產品代碼PPW
諮詢委員會履歷
決定相當於

器材摘要

prolaio eVO2peak Module (Version 1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Prolaio, Inc.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K252204. The device is classified under product code PPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the prolaio eVO2peak Module (Version 1.0)?

prolaio eVO2peak Module (Version 1.0) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Prolaio, Inc.. The 510(k) number is K252204.

When did prolaio eVO2peak Module (Version 1.0) receive FDA 510(k) clearance?

prolaio eVO2peak Module (Version 1.0) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K252204.

Who is the listed applicant for prolaio eVO2peak Module (Version 1.0)?

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

What is the FDA product code for prolaio eVO2peak Module (Version 1.0)?

The FDA product code for prolaio eVO2peak Module (Version 1.0) is PPW.

相關臨床試驗

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相關器械（代碼：PPW）

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。

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官方來源

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