FDA 510(k)

PillCam SB 3 カプセル内視鏡システム、PillCam ソフトウェア 9.0E

K番号: K211684 · 2021-08-27

決定日2021-08-27

製品コードNEZ

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging Ltd. (Medtronic). It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K211684. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Given Imaging Ltd. (Medtronic). The 510(k) number is K211684.

When did PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E receive FDA 510(k) clearance?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E received FDA 510(k) clearance on 2021-08-27, under 510(k) number K211684.

Who is the listed applicant for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

The FDA 510(k) record lists Given Imaging Ltd. (Medtronic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

The FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is NEZ.

申請者としてGiven Imaging Ltd. (Medtronic)を記載するその他の記録

K230991PillCam SB 3 カプセル内視鏡システム、PillCam ソフトウェア 9.0E

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