FDA 510(k)

パウリタンフェカルオプティ-スウェブコレクションおよび輸送システム

K番号: K162284 · 2016-11-04

決定日2016-11-04

製品コードJSM

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてPuritan Medical Products, LLCを記載するその他の記録

K242820パウリタン PurSafe Plus コレクションおよび輸送システム K160082プリマス・オプティトランスカリー・ブレアコレクションおよび輸送システム

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