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FDA 510(k)

DANPLEX SCREENING AUDIOMETER

K-Number: K923074 · 1992-09-23

ApplicantLife-Tech Intl., Inc.
Decision Date1992-09-23
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DANPLEX SCREENING AUDIOMETER 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 1992-09-23 under 510(k) number K923074. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANPLEX SCREENING AUDIOMETER?

DANPLEX SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1992-09-23. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K923074.

When did DANPLEX SCREENING AUDIOMETER receive FDA 510(k) clearance?

DANPLEX SCREENING AUDIOMETER received FDA 510(k) clearance on 1992-09-23, under 510(k) number K923074.

Who is the listed applicant for DANPLEX SCREENING AUDIOMETER?

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 SCREENING AUDIOMETER?

The FDA product code for DANPLEX SCREENING AUDIOMETER is EWO.

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

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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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