FDA 510(k)

LetsGetChecked インプレス

K番号: K242680 · 2025-01-13

申請者Privapath Diagnostics Ltd (Dba Letsgetchecked)

決定日2025-01-13

製品コードFMK

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定Unknown

医療機器の概要

LetsGetChecked Impress is the device name listed in this FDA 510(k) record. The listed applicant is Privapath Diagnostics Ltd (Dba Letsgetchecked). It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K242680. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

よくある質問

What is the LetsGetChecked Impress?

LetsGetChecked Impress is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Privapath Diagnostics Ltd (Dba Letsgetchecked). The 510(k) number is K242680.

When did LetsGetChecked Impress receive FDA 510(k) clearance?

LetsGetChecked Impress received FDA 510(k) clearance on 2025-01-13, under 510(k) number K242680.

Who is the listed applicant for LetsGetChecked Impress?

The FDA 510(k) record lists Privapath Diagnostics Ltd (Dba Letsgetchecked) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LetsGetChecked Impress?

The FDA product code for LetsGetChecked Impress is FMK.

公式ソース

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LetsGetChecked インプレス

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FMK）

公式ソース