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FDA 510(k)

SYNAP-I INFANT SENSORY ASSESSMENT UNIT

K-Number: K810138 · 1981-04-03

ApplicantInfant Hearing Assessment Foundation
Decision Date1981-04-03
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNAP-I INFANT SENSORY ASSESSMENT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Infant Hearing Assessment Foundation. It received FDA 510(k) clearance on 1981-04-03 under 510(k) number K810138. 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 SYNAP-I INFANT SENSORY ASSESSMENT UNIT?

SYNAP-I INFANT SENSORY ASSESSMENT UNIT is a medical device that received FDA 510(k) clearance on 1981-04-03. The listed applicant is Infant Hearing Assessment Foundation. The 510(k) number is K810138.

When did SYNAP-I INFANT SENSORY ASSESSMENT UNIT receive FDA 510(k) clearance?

SYNAP-I INFANT SENSORY ASSESSMENT UNIT received FDA 510(k) clearance on 1981-04-03, under 510(k) number K810138.

Who is the listed applicant for SYNAP-I INFANT SENSORY ASSESSMENT UNIT?

The FDA 510(k) record lists Infant Hearing Assessment Foundation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNAP-I INFANT SENSORY ASSESSMENT UNIT?

The FDA product code for SYNAP-I INFANT SENSORY ASSESSMENT UNIT is GWJ.

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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

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

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