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FDA 510(k)

DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT

K-Number: K923071 · 1992-09-28

ApplicantLife-Tech Intl., Inc.
Decision Date1992-09-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1992-09-28 under 510(k) number K923071. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT?

DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT is a medical device that received FDA 510(k) clearance on 1992-09-28. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K923071.

When did DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT receive FDA 510(k) clearance?

DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT received FDA 510(k) clearance on 1992-09-28, under 510(k) number K923071.

Who is the listed applicant for DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT?

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

What is the FDA product code for DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT?

The FDA product code for DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT is ESD.

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Other records listing Life-Tech Intl., Inc. as applicant

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Related Devices (Code: ESD)

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.

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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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