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FDA 510(k)

Bosley Booster 128 激光帽；Bosley Booster 162 激光帽；Bosley Booster 288 激光帽

K 號：K240456 · 2024-05-22

申請人Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
決定日期2024-05-22
產品代碼OAP
諮詢委員會PM
決定相當於

器材摘要

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap is the device name listed in this FDA 510(k) record. The listed applicant is Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K240456. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap?

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. The 510(k) number is K240456.

When did Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap receive FDA 510(k) clearance?

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap received FDA 510(k) clearance on 2024-05-22, under 510(k) number K240456.

Who is the listed applicant for Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap?

The FDA 510(k) record lists Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap?

The FDA product code for Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap is OAP.

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：OAP）

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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