FDA 510(k)

羅塞塔SM，羅塞塔SP

K 號：K260859 · 2026-06-11

決定日期2026-06-11

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Rosetta SM, Rosetta SP is the device name listed in this FDA 510(k) record. The listed applicant is Hass Corp.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K260859. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rosetta SM, Rosetta SP?

Rosetta SM, Rosetta SP is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Hass Corp.. The 510(k) number is K260859.

When did Rosetta SM, Rosetta SP receive FDA 510(k) clearance?

Rosetta SM, Rosetta SP received FDA 510(k) clearance on 2026-06-11, under 510(k) number K260859.

Who is the listed applicant for Rosetta SM, Rosetta SP?

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

What is the FDA product code for Rosetta SM, Rosetta SP?

The FDA product code for Rosetta SM, Rosetta SP is EIH.

其他以 Hass Corp. 為申請人之記錄

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相關器械（代碼：EIH）

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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官方來源

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