FDA 510(k)

防篡改蓋，適用於ENFit針筒

K 號：K170672 · 2017-10-06

申請人International Medical Industries, Inc.

決定日期2017-10-06

產品代碼PNR

諮詢委員會GU

決定相當於

器材摘要

Tamper Evident Cap For use with ENFit Syringes is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K170672. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tamper Evident Cap For use with ENFit Syringes?

Tamper Evident Cap For use with ENFit Syringes is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K170672.

When did Tamper Evident Cap For use with ENFit Syringes receive FDA 510(k) clearance?

Tamper Evident Cap For use with ENFit Syringes received FDA 510(k) clearance on 2017-10-06, under 510(k) number K170672.

Who is the listed applicant for Tamper Evident Cap For use with ENFit Syringes?

The FDA 510(k) record lists International Medical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tamper Evident Cap For use with ENFit Syringes?

The FDA product code for Tamper Evident Cap For use with ENFit Syringes is PNR.

其他以 International Medical Industries, Inc. 為申請人之記錄

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相關器械（代碼：PNR）

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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