FDA 510(k)

SAM 3.0 多小時連續超聲波設備

K 號：K260076 · 2026-04-28

決定日期2026-04-28

產品代碼PFW

諮詢委員會PM

決定相當於

器材摘要

SAM 3.0 Multi-Hour Continuous Ultrasound Device is the device name listed in this FDA 510(k) record. The listed applicant is ZetrOZ Systems, LLC. It received FDA 510(k) clearance on 2026-04-28 under 510(k) number K260076. The device is classified under product code PFW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SAM 3.0 Multi-Hour Continuous Ultrasound Device?

SAM 3.0 Multi-Hour Continuous Ultrasound Device is a medical device that received FDA 510(k) clearance on 2026-04-28. The listed applicant is ZetrOZ Systems, LLC. The 510(k) number is K260076.

When did SAM 3.0 Multi-Hour Continuous Ultrasound Device receive FDA 510(k) clearance?

SAM 3.0 Multi-Hour Continuous Ultrasound Device received FDA 510(k) clearance on 2026-04-28, under 510(k) number K260076.

Who is the listed applicant for SAM 3.0 Multi-Hour Continuous Ultrasound Device?

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

What is the FDA product code for SAM 3.0 Multi-Hour Continuous Ultrasound Device?

The FDA product code for SAM 3.0 Multi-Hour Continuous Ultrasound Device is PFW.

其他以 ZetrOZ Systems, LLC 為申請人之記錄

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。

K233210sam CS 長效超音波設備 K223019sam 2.0 長波超音波設備 K211513sam X1 長效超音波設備 K191568sam 2.0 長效超音波系統

相關器械（代碼：PFW）

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。

K233210sam CS 長效超音波設備ZetrOZ Systems, LLC K223019sam 2.0 長波超音波設備ZetrOZ Systems, LLC K221210痛盾MD PLUSNanovibronix, Inc.K211513sam X1 長效超音波設備ZetrOZ Systems, LLC K191568sam 2.0 長效超音波系統ZetrOZ Systems, LLC

官方來源

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