FDA 510(k)

SpO2感測器

K 號：K202851 · 2020-11-27

決定日期2020-11-27

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Spo2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2020-11-27 under 510(k) number K202851. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spo2 Sensor?

Spo2 Sensor is a medical device that received FDA 510(k) clearance on 2020-11-27. The listed applicant is Jkh USA, LLC. The 510(k) number is K202851.

When did Spo2 Sensor receive FDA 510(k) clearance?

Spo2 Sensor received FDA 510(k) clearance on 2020-11-27, under 510(k) number K202851.

Who is the listed applicant for Spo2 Sensor?

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

What is the FDA product code for Spo2 Sensor?

The FDA product code for Spo2 Sensor is DQA.

其他以 Jkh USA, LLC 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。

K203636PlusCare 體溫探針，皮膚類型：PT2252-AS、PTHP-AS、PTMQ-AS、PTSW-AS、PTSM-15AS、PTSL-AS、PTMR-AS；直腸類型：PT2252-AG、PTHP-AG、PTMQ-AG、PTSW-AG、PTSM-15AG、PTSL-AG、PTMR-AG K203635病人監護線材 K203652血壓袖帶, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, 血壓袖帶, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, 血壓袖帶, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, 血壓袖帶, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, 血壓袖帶, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D K201645按摩壓縮靴 K201470一次性醫療口罩 K182671Medi-Direct 神經電刺激筆

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相關器械（代碼：DQA）

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。

K252821可重用成人SpO2夾式感測器（3m）（M1196A）；可重用成人SpO2夾式感測器（0.9m）（M1196T）Philips Medizin Systeme Böblingen GmbH K252655心脈血氧濃度計（PO-A2AO、PO-A2AT、PO-A3AO、PO-H1AO、PO-B1AO、PO-C5AO、PO-C5AT、PO-C6AO、PO-C6AT）Shenzhen Imdk Medical Technology Co., Ltd.K253887鼻翼SpO2感測器（989803205381）；鼻翼SpO2感測器（989803205391）；鼻翼Sp02感測器（989803205401）Philips Medizin Systeme K260931Unimed可重用手指夾式SpO2感測器（U403-49R及U103-49R）Unimed Medical Supplies, Inc.K252448AViTA脉搏血氧儀 (SP61)Avita Corporation K252805YUWELL®手指血氧計（YX105、YX106、YX110、YX310）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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