FDA 510(k)

sam 2.0 長效超音波系統

K 號：K191568 · 2020-03-06

決定日期2020-03-06

產品代碼PFW

諮詢委員會PM

決定相當於

器材摘要

sam 2.0 Long Duration Ultrasound System 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 2020-03-06 under 510(k) number K191568. 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 2.0 Long Duration Ultrasound System?

sam 2.0 Long Duration Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is ZetrOZ Systems, LLC. The 510(k) number is K191568.

When did sam 2.0 Long Duration Ultrasound System receive FDA 510(k) clearance?

sam 2.0 Long Duration Ultrasound System received FDA 510(k) clearance on 2020-03-06, under 510(k) number K191568.

Who is the listed applicant for sam 2.0 Long Duration Ultrasound System?

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 2.0 Long Duration Ultrasound System?

The FDA product code for sam 2.0 Long Duration Ultrasound System 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。

K260076SAM 3.0 多小時連續超聲波設備 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

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。

K260076SAM 3.0 多小時連續超聲波設備ZetrOZ Systems, LLC 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

官方來源

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