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FDA 510(k)

ALGO 3 NEWBORN HEARING SCREENER

K-Number: K013137 · 2001-10-16

ApplicantNatus Medical, Inc.
Decision Date2001-10-16
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALGO 3 NEWBORN HEARING SCREENER is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical, Inc.. It received FDA 510(k) clearance on 2001-10-16 under 510(k) number K013137. 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 3 NEWBORN HEARING SCREENER?

ALGO 3 NEWBORN HEARING SCREENER is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Natus Medical, Inc.. The 510(k) number is K013137.

When did ALGO 3 NEWBORN HEARING SCREENER receive FDA 510(k) clearance?

ALGO 3 NEWBORN HEARING SCREENER received FDA 510(k) clearance on 2001-10-16, under 510(k) number K013137.

Who is the listed applicant for ALGO 3 NEWBORN HEARING SCREENER?

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

What is the FDA product code for ALGO 3 NEWBORN HEARING SCREENER?

The FDA product code for ALGO 3 NEWBORN HEARING SCREENER is GWJ.

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Other records listing Natus Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093304PROTEKTOR 32K093949OLYMPIC BRAINZ MONITOR MODEL OBM70001K090019NATUS NEUROWORKS, MODEL 104196K083371NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)K073665ALGO 5 NEWBORN HEARING SCREENERK051869NEOBLUE COZY LED PHOTOTHERAPY SYSTEM

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Related Devices (Code: GWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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