FDA 510(k)

普里坦糞便優選採集及運輸系統

K 號：K162284 · 2016-11-04

決定日期2016-11-04

產品代碼JSM

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Puritan Fecal Opti-Swab Collection and Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Medical Products, LLC. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162284. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Puritan Fecal Opti-Swab Collection and Transport System?

Puritan Fecal Opti-Swab Collection and Transport System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Puritan Medical Products, LLC. The 510(k) number is K162284.

When did Puritan Fecal Opti-Swab Collection and Transport System receive FDA 510(k) clearance?

Puritan Fecal Opti-Swab Collection and Transport System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162284.

Who is the listed applicant for Puritan Fecal Opti-Swab Collection and Transport System?

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

What is the FDA product code for Puritan Fecal Opti-Swab Collection and Transport System?

The FDA product code for Puritan Fecal Opti-Swab Collection and Transport System is JSM.

其他以 Puritan Medical Products, 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。

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相關器械（代碼：JSM）

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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