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FDA 510(k)

泰克RMD（泰克機械化移動設備）TEKRMD02，TEKRMD03，TEKRMD04，TEKRMD04，TEKRMD05，TEKRMD06，TEKRMD07，TEKRMD08

K 號：K191334 · 2020-05-29

申請人Matia Robotics (Us), Inc.
決定日期2020-05-29
產品代碼IPL
諮詢委員會PM
決定相當於

器材摘要

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 is the device name listed in this FDA 510(k) record. The listed applicant is Matia Robotics (Us), Inc.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K191334. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08?

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Matia Robotics (Us), Inc.. The 510(k) number is K191334.

When did Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 receive FDA 510(k) clearance?

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 received FDA 510(k) clearance on 2020-05-29, under 510(k) number K191334.

Who is the listed applicant for Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08?

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

What is the FDA product code for Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08?

The FDA product code for Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 is IPL.

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。

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相關器械（代碼：IPL）

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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