Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KODI OPTICAL CO., LTD. SUNGLASSES

K-Number: K944484 · 1994-11-10

Decision Date1994-11-10
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KODI OPTICAL CO., LTD. SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Kodi Optical Co. , Ltd.. It received FDA 510(k) clearance on 1994-11-10 under 510(k) number K944484. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODI OPTICAL CO., LTD. SUNGLASSES?

KODI OPTICAL CO., LTD. SUNGLASSES is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Kodi Optical Co. , Ltd.. The 510(k) number is K944484.

When did KODI OPTICAL CO., LTD. SUNGLASSES receive FDA 510(k) clearance?

KODI OPTICAL CO., LTD. SUNGLASSES received FDA 510(k) clearance on 1994-11-10, under 510(k) number K944484.

Who is the listed applicant for KODI OPTICAL CO., LTD. SUNGLASSES?

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

What is the FDA product code for KODI OPTICAL CO., LTD. SUNGLASSES?

The FDA product code for KODI OPTICAL CO., LTD. SUNGLASSES is HQY.

Related Clinical Trials

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.

Related Devices (Code: HQY)

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.

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.

↑