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FDA 510(k)

OPTIKOS SHAMI, INC. SUNGLASSES

K-Number: K934197 · 1994-01-25

ApplicantOptikos Shami, Inc.
Decision Date1994-01-25
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIKOS SHAMI, INC. SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Optikos Shami, Inc.. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K934197. 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 OPTIKOS SHAMI, INC. SUNGLASSES?

OPTIKOS SHAMI, INC. SUNGLASSES is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is Optikos Shami, Inc.. The 510(k) number is K934197.

When did OPTIKOS SHAMI, INC. SUNGLASSES receive FDA 510(k) clearance?

OPTIKOS SHAMI, INC. SUNGLASSES received FDA 510(k) clearance on 1994-01-25, under 510(k) number K934197.

Who is the listed applicant for OPTIKOS SHAMI, INC. SUNGLASSES?

The FDA 510(k) record lists Optikos Shami, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIKOS SHAMI, INC. SUNGLASSES?

The FDA product code for OPTIKOS SHAMI, INC. 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Optikos Shami, Inc. as applicant

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.

K934198OPTIKOS SHAMI, INC. SPECTACLE FRAMES

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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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