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FDA 510(k)

XLTEK LED GOGGLES, MODEL LED-01

K-Number: K011794 · 2001-10-01

ApplicantExcel Tech. , Ltd.
Decision Date2001-10-01
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XLTEK LED GOGGLES, MODEL LED-01 is the device name listed in this FDA 510(k) record. The listed applicant is Excel Tech. , Ltd.. It received FDA 510(k) clearance on 2001-10-01 under 510(k) number K011794. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XLTEK LED GOGGLES, MODEL LED-01?

XLTEK LED GOGGLES, MODEL LED-01 is a medical device that received FDA 510(k) clearance on 2001-10-01. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K011794.

When did XLTEK LED GOGGLES, MODEL LED-01 receive FDA 510(k) clearance?

XLTEK LED GOGGLES, MODEL LED-01 received FDA 510(k) clearance on 2001-10-01, under 510(k) number K011794.

Who is the listed applicant for XLTEK LED GOGGLES, MODEL LED-01?

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

What is the FDA product code for XLTEK LED GOGGLES, MODEL LED-01?

The FDA product code for XLTEK LED GOGGLES, MODEL LED-01 is GWE.

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Other records listing Excel Tech. , Ltd. 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.

K062549XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238K061269XLTEK CLEAN SIGNAL ADHESIVE ELECTRODESK053386XLTEK EMU40 EEG HEADBOX, MODEL PK1072K053058XLTEK NEUROPATH, MODEL PK1070K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

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Related Devices (Code: GWE)

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.

K221471E3 and ProfileDiagnosys, LLCK212936Vision Monitor- MonCvONEMetrovisionK211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovisionK200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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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