FDA 510(k)

IRENE ロッキング・コンプレッション・プレート・システム

K番号: K151508 · 2016-02-25

申請者Tianjin Zhengtian Medical Instrument Co., Ltd.

決定日2016-02-25

製品コードHRS

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

IRENE Locking Compression Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K151508. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the IRENE Locking Compression Plate System?

IRENE Locking Compression Plate System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. The 510(k) number is K151508.

When did IRENE Locking Compression Plate System receive FDA 510(k) clearance?

IRENE Locking Compression Plate System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K151508.

Who is the listed applicant for IRENE Locking Compression Plate System?

The FDA 510(k) record lists Tianjin Zhengtian Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRENE Locking Compression Plate System?

The FDA product code for IRENE Locking Compression Plate System is HRS.

申請者としてTianjin Zhengtian Medical Instrument Co., Ltd.を記載するその他の記録

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