FDA 510(k)

ALGO Pro 新生兒聽力檢測器 (ALGO Pro)

K 號：K233649 · 2024-03-08

申請人Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

決定日期2024-03-08

產品代碼GWJ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.