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FDA 510(k)

SUNGLASSES (NON-PRESCRIPTION)

K-Number: K940778 · 1994-04-06

Decision Date1994-04-06
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUNGLASSES (NON-PRESCRIPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Hwa Meei Optical Co., Ltd.. It received FDA 510(k) clearance on 1994-04-06 under 510(k) number K940778. 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 SUNGLASSES (NON-PRESCRIPTION)?

SUNGLASSES (NON-PRESCRIPTION) is a medical device that received FDA 510(k) clearance on 1994-04-06. The listed applicant is Hwa Meei Optical Co., Ltd.. The 510(k) number is K940778.

When did SUNGLASSES (NON-PRESCRIPTION) receive FDA 510(k) clearance?

SUNGLASSES (NON-PRESCRIPTION) received FDA 510(k) clearance on 1994-04-06, under 510(k) number K940778.

Who is the listed applicant for SUNGLASSES (NON-PRESCRIPTION)?

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

What is the FDA product code for SUNGLASSES (NON-PRESCRIPTION)?

The FDA product code for SUNGLASSES (NON-PRESCRIPTION) 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

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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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