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FDA 510(k)

EAR ELECTRODE-ADULT & PEDIATRIC

K-Number: K780537 · 1978-06-02

ApplicantLife-Tech Instruments, Inc.
Decision Date1978-06-02
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EAR ELECTRODE-ADULT & PEDIATRIC 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 1978-06-02 under 510(k) number K780537. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR ELECTRODE-ADULT & PEDIATRIC?

EAR ELECTRODE-ADULT & PEDIATRIC is a medical device that received FDA 510(k) clearance on 1978-06-02. The listed applicant is Life-Tech Instruments, Inc.. The 510(k) number is K780537.

When did EAR ELECTRODE-ADULT & PEDIATRIC receive FDA 510(k) clearance?

EAR ELECTRODE-ADULT & PEDIATRIC received FDA 510(k) clearance on 1978-06-02, under 510(k) number K780537.

Who is the listed applicant for EAR ELECTRODE-ADULT & PEDIATRIC?

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 EAR ELECTRODE-ADULT & PEDIATRIC?

The FDA product code for EAR ELECTRODE-ADULT & PEDIATRIC is GXY.

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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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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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