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FDA 510(k)

CUSTOM LITE

K-Number: K844321 · 1984-11-27

ApplicantBuchmann Optical Industries
Decision Date1984-11-27
Product CodeHQG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CUSTOM LITE is the device name listed in this FDA 510(k) record. The listed applicant is Buchmann Optical Industries. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K844321. The device is classified under product code HQG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM LITE?

CUSTOM LITE is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Buchmann Optical Industries. The 510(k) number is K844321.

When did CUSTOM LITE receive FDA 510(k) clearance?

CUSTOM LITE received FDA 510(k) clearance on 1984-11-27, under 510(k) number K844321.

Who is the listed applicant for CUSTOM LITE?

The FDA 510(k) record lists Buchmann Optical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTOM LITE?

The FDA product code for CUSTOM LITE is HQG.

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Related Devices (Code: HQG)

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

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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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