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FDA 510(k)

TULUX-FILTER

K-Number: K892517 · 1989-08-21

ApplicantEspe GmbH (Us)
Decision Date1989-08-21
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TULUX-FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH (Us). It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K892517. 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 TULUX-FILTER?

TULUX-FILTER is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Espe GmbH (Us). The 510(k) number is K892517.

When did TULUX-FILTER receive FDA 510(k) clearance?

TULUX-FILTER received FDA 510(k) clearance on 1989-08-21, under 510(k) number K892517.

Who is the listed applicant for TULUX-FILTER?

The FDA 510(k) record lists Espe GmbH (Us) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TULUX-FILTER?

The FDA product code for TULUX-FILTER is EBZ.

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Other records listing Espe GmbH (Us) 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.

K925027PHOTAC-FIL APLICAPK913966SONO(R) -CEMK915005PHOTAC-BOND APLICAP, MODIFICATIONK913857ROCATEC(R) -PLUSK913965ESPE(R) -SILK905604VISIO-GEM ART-SYSTEM

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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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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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