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FDA 510(k)

GLAID OCULAR ELECTROPHYSIOLOGY DEVICE

K-Number: K043367 · 2005-11-17

ApplicantLace Electronica S.R.L.
Decision Date2005-11-17
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GLAID OCULAR ELECTROPHYSIOLOGY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Lace Electronica S.R.L.. It received FDA 510(k) clearance on 2005-11-17 under 510(k) number K043367. 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 GLAID OCULAR ELECTROPHYSIOLOGY DEVICE?

GLAID OCULAR ELECTROPHYSIOLOGY DEVICE is a medical device that received FDA 510(k) clearance on 2005-11-17. The listed applicant is Lace Electronica S.R.L.. The 510(k) number is K043367.

When did GLAID OCULAR ELECTROPHYSIOLOGY DEVICE receive FDA 510(k) clearance?

GLAID OCULAR ELECTROPHYSIOLOGY DEVICE received FDA 510(k) clearance on 2005-11-17, under 510(k) number K043367.

Who is the listed applicant for GLAID OCULAR ELECTROPHYSIOLOGY DEVICE?

The FDA 510(k) record lists Lace Electronica S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLAID OCULAR ELECTROPHYSIOLOGY DEVICE?

The FDA product code for GLAID OCULAR ELECTROPHYSIOLOGY DEVICE is GWE.

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Related Devices (Code: GWE)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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