FDA 510(k)

Wesper實驗室

K 號：K203343 · 2021-12-21

決定日期2021-12-21

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

Wesper Lab is the device name listed in this FDA 510(k) record. The listed applicant is Wesper, Inc.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K203343. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wesper Lab?

Wesper Lab is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Wesper, Inc.. The 510(k) number is K203343.

When did Wesper Lab receive FDA 510(k) clearance?

Wesper Lab received FDA 510(k) clearance on 2021-12-21, under 510(k) number K203343.

Who is the listed applicant for Wesper Lab?

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

What is the FDA product code for Wesper Lab?

The FDA product code for Wesper Lab is MNR.

其他以 Wesper, Inc. 為申請人之記錄

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。

K252628CASSIE K221816Wesper實驗室 K213515WesperO2

相關器械（代碼：MNR）

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。

K260949一次性睡眠監測帶（CNSAC）CNSAC Medshop GmbH K254042觀察者PAT SWItamar Medical , Ltd.K260050WRAP系統Huneo, LLC K253148RX-1 睡眠Vivaquant, Inc. Dba Rhythm Express K252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

官方來源

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