FDA 510(k)

Apis

K 號：K182725 · 2019-05-31

決定日期2019-05-31

產品代碼FRO

決定相當於

器材摘要

Apis is the device name listed in this FDA 510(k) record. The listed applicant is Sweetbio, Inc.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K182725. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Apis?

Apis is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Sweetbio, Inc.. The 510(k) number is K182725.

When did Apis receive FDA 510(k) clearance?

Apis received FDA 510(k) clearance on 2019-05-31, under 510(k) number K182725.

Who is the listed applicant for Apis?

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

What is the FDA product code for Apis?

The FDA product code for Apis is FRO. This falls under the Anesthesiology category.

其他以 Sweetbio, Inc. 為申請人之記錄

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K222143APIS (R), VERIS (TM)

相關器械（代碼：FRO）

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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