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FDA 510(k)

FRAME

K-Number: K940312 · 1994-03-01

ApplicantLanner Enterprise Co., Ltd.
Decision Date1994-03-01
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Lanner Enterprise Co., Ltd.. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K940312. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRAME?

FRAME is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is Lanner Enterprise Co., Ltd.. The 510(k) number is K940312.

When did FRAME receive FDA 510(k) clearance?

FRAME received FDA 510(k) clearance on 1994-03-01, under 510(k) number K940312.

Who is the listed applicant for FRAME?

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

What is the FDA product code for FRAME?

The FDA product code for FRAME is HQZ.

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Related PubMed Literature

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.

PMID: 42834824India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.Expert review of medical devices ()PMID: 42749521Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.Clinical therapeutics ()PMID: 42714465Artificial Intelligence in Indian Dermatology: An IADVL Academy Position Statement and Policy Framework for Safe, Equitable, and Effective Adoption.Indian dermatology online journal ()PMID: 42674147Public transparency and physicochemical standardization in the regulation of PMMA dermal fillers: a comparative analysis of FDA, EU MDR, and ANVISA frameworks.Regulatory toxicology and pharmacology : RTP ()

Other records listing Lanner Enterprise Co., Ltd. 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.

K940311SUNGLASSES AND SPORT SUNGLASSES

Related Devices (Code: HQZ)

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.

K952597VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEWPoint of View Optical Outlet, Inc.K944313SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.K945770OPTICAL FRAMESRamada Optics, Inc.K945392SPECTACLE FRAMESeo Han Corp., Ltd.K945176SPECTACLE FRAME OR EYEGLASS FRAMESOptipia Trading Co.K945350FRAME, SPECTACLESTaiwan Eva Industrial Co., Inc.

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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