FDA 510(k)

ALGO Pro新生儿听力筛查器（ALGO Pro）

K号: K233649 · 2024-03-08

申请人Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

决定日期2024-03-08

产品代码GWJ

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决定实质等同

器械摘要

ALGO Pro Newborn Hearing Screener (ALGO Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K233649. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ALGO Pro Newborn Hearing Screener (ALGO Pro)?

ALGO Pro Newborn Hearing Screener (ALGO Pro) is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K233649.

When did ALGO Pro Newborn Hearing Screener (ALGO Pro) receive FDA 510(k) clearance?

ALGO Pro Newborn Hearing Screener (ALGO Pro) received FDA 510(k) clearance on 2024-03-08, under 510(k) number K233649.

Who is the listed applicant for ALGO Pro Newborn Hearing Screener (ALGO Pro)?

The FDA 510(k) record lists Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALGO Pro Newborn Hearing Screener (ALGO Pro)?

The FDA product code for ALGO Pro Newborn Hearing Screener (ALGO Pro) is GWJ.

列明Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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