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FDA 510(k)

ALGO Pro Newborn Hearing Screener (ALGO Pro)

K-Number: K233649 · 2024-03-08

ApplicantNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision Date2024-03-08
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) as applicant

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Related Devices (Code: GWJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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