FDA 510(k)

極薄003，零零三

K 號：K192669 · 2020-07-24

決定日期2020-07-24

產品代碼HIS

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Extremely Thin 003, ZERO ZERO THREE is the device name listed in this FDA 510(k) record. The listed applicant is Okamoto USA, Inc.. It received FDA 510(k) clearance on 2020-07-24 under 510(k) number K192669. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Extremely Thin 003, ZERO ZERO THREE?

Extremely Thin 003, ZERO ZERO THREE is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is Okamoto USA, Inc.. The 510(k) number is K192669.

When did Extremely Thin 003, ZERO ZERO THREE receive FDA 510(k) clearance?

Extremely Thin 003, ZERO ZERO THREE received FDA 510(k) clearance on 2020-07-24, under 510(k) number K192669.

Who is the listed applicant for Extremely Thin 003, ZERO ZERO THREE?

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

What is the FDA product code for Extremely Thin 003, ZERO ZERO THREE?

The FDA product code for Extremely Thin 003, ZERO ZERO THREE is HIS.

其他以 Okamoto USA, Inc. 為申請人之記錄

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K252622男性乳膠避孕套 HA K2435840.04 ZERO ZERO FOUR Male Latex Condom K203541岡本002潤滑聚氨酯男性避孕套

相關器械（代碼：HIS）

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。

官方來源

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