FDA 510(k)

mi-eye 3 ネードスコープおよびカニュラ、mi-tablet 3

K番号: K212556 · 2021-09-15

決定日2021-09-15

製品コードHRX

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

mi-eye 3 needlescope with cannula, mi-tablet 3 is the device name listed in this FDA 510(k) record. The listed applicant is Trice Medical, Inc.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K212556. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the mi-eye 3 needlescope with cannula, mi-tablet 3?

mi-eye 3 needlescope with cannula, mi-tablet 3 is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Trice Medical, Inc.. The 510(k) number is K212556.

When did mi-eye 3 needlescope with cannula, mi-tablet 3 receive FDA 510(k) clearance?

mi-eye 3 needlescope with cannula, mi-tablet 3 received FDA 510(k) clearance on 2021-09-15, under 510(k) number K212556.

Who is the listed applicant for mi-eye 3 needlescope with cannula, mi-tablet 3?

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

What is the FDA product code for mi-eye 3 needlescope with cannula, mi-tablet 3?

The FDA product code for mi-eye 3 needlescope with cannula, mi-tablet 3 is HRX.

申請者としてTrice Medical, Inc.を記載するその他の記録

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