FDA 510(k)

預壓

K 號：K201835 · 2021-07-08

決定日期2021-07-08

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

PRE-SURE is the device name listed in this FDA 510(k) record. The listed applicant is Lazarus 3D, Inc.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K201835. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PRE-SURE?

PRE-SURE is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Lazarus 3D, Inc.. The 510(k) number is K201835.

When did PRE-SURE receive FDA 510(k) clearance?

PRE-SURE received FDA 510(k) clearance on 2021-07-08, under 510(k) number K201835.

Who is the listed applicant for PRE-SURE?

The FDA 510(k) record lists Lazarus 3D, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-SURE?

The FDA product code for PRE-SURE is LLZ.

相關器械（代碼：LLZ）

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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