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FDA 510(k)

KULZER TRANSLUX EC

K-Number: K892456 · 1989-06-14

ApplicantKulzer, Inc.
Decision Date1989-06-14
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KULZER TRANSLUX EC is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1989-06-14 under 510(k) number K892456. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KULZER TRANSLUX EC?

KULZER TRANSLUX EC is a medical device that received FDA 510(k) clearance on 1989-06-14. The listed applicant is Kulzer, Inc.. The 510(k) number is K892456.

When did KULZER TRANSLUX EC receive FDA 510(k) clearance?

KULZER TRANSLUX EC received FDA 510(k) clearance on 1989-06-14, under 510(k) number K892456.

Who is the listed applicant for KULZER TRANSLUX EC?

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

What is the FDA product code for KULZER TRANSLUX EC?

The FDA product code for KULZER TRANSLUX EC is EBZ.

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Other records listing Kulzer, Inc. as applicant

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Related Devices (Code: EBZ)

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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