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FDA 510(k)

ELECTRIC RESPONSE AUDIOMETER

K-Number: K780540 · 1978-04-21

ApplicantLife-Tech Instruments, Inc.
Decision Date1978-04-21
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRIC RESPONSE AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Instruments, Inc.. It received FDA 510(k) clearance on 1978-04-21 under 510(k) number K780540. 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 ELECTRIC RESPONSE AUDIOMETER?

ELECTRIC RESPONSE AUDIOMETER is a medical device that received FDA 510(k) clearance on 1978-04-21. The listed applicant is Life-Tech Instruments, Inc.. The 510(k) number is K780540.

When did ELECTRIC RESPONSE AUDIOMETER receive FDA 510(k) clearance?

ELECTRIC RESPONSE AUDIOMETER received FDA 510(k) clearance on 1978-04-21, under 510(k) number K780540.

Who is the listed applicant for ELECTRIC RESPONSE AUDIOMETER?

The FDA 510(k) record lists Life-Tech Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRIC RESPONSE AUDIOMETER?

The FDA product code for ELECTRIC RESPONSE AUDIOMETER is GWJ.

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Other records listing Life-Tech Instruments, 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.

K812177LIFE-TECH #1857 PRESSURE/POLOT MODULEK812179LIFE-TECH #1753 BIOFEEDBACK TRAINERK812180LIFE-TECH #5102 VISULABK812178LIFE-TECH #'S 1106/1156 UROLABSK800112AMBLYOPIA TRAINERK790663MODEL 1750 STANDING URINAL

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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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