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FDA 510(k)

MESORAM® 皮內針 (710301)；MESORAM® 皮內針 (710302)；MESORAM® 皮內針 (712305)；MESORAM® 皮內針 (712315)；MESORAM® 皮內針 (710303)；MESORAM® 皮內針 (710307)；MESORAM® 皮內針 (710306)；MESORAM® 皮內針 (712308)；MESORAM® 皮內針 (712318)；MESORAM® 皮內針 (712303)；MESORAM® 皮內針 (712307)；MESORAM® 皮內針 (712306)；MESORAM® 皮內針 (812400)；MESORAM®

K 號：K230070 · 2023-10-05

申請人Promamedical, Inc.
決定日期2023-10-05
產品代碼FMI
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® is the device name listed in this FDA 510(k) record. The listed applicant is Promamedical, Inc.. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K230070. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®?

MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Promamedical, Inc.. The 510(k) number is K230070.

When did MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® receive FDA 510(k) clearance?

MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® received FDA 510(k) clearance on 2023-10-05, under 510(k) number K230070.

Who is the listed applicant for MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®?

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

What is the FDA product code for MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®?

The FDA product code for MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® is FMI.

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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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