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FDA 510(k)

L.E.D. GOGGLES, MODEL 580-LEDGOG

K-Number: K852533 · 1985-12-12

ApplicantBio-Logic Systems Corp.
Decision Date1985-12-12
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

L.E.D. GOGGLES, MODEL 580-LEDGOG is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Logic Systems Corp.. It received FDA 510(k) clearance on 1985-12-12 under 510(k) number K852533. 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 L.E.D. GOGGLES, MODEL 580-LEDGOG?

L.E.D. GOGGLES, MODEL 580-LEDGOG is a medical device that received FDA 510(k) clearance on 1985-12-12. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K852533.

When did L.E.D. GOGGLES, MODEL 580-LEDGOG receive FDA 510(k) clearance?

L.E.D. GOGGLES, MODEL 580-LEDGOG received FDA 510(k) clearance on 1985-12-12, under 510(k) number K852533.

Who is the listed applicant for L.E.D. GOGGLES, MODEL 580-LEDGOG?

The FDA 510(k) record lists Bio-Logic Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for L.E.D. GOGGLES, MODEL 580-LEDGOG?

The FDA product code for L.E.D. GOGGLES, MODEL 580-LEDGOG is GWE.

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Related Devices (Code: GWE)

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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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