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)

OPD-SCAN, MODELS ARK-10000 AND ARK-9000

K-Number: K003299 · 2001-03-09

ApplicantNidek Co., Ltd.
Decision Date2001-03-09
Product CodeHLQ
Advisory CommitteeOP
DecisionUnknown

Device Summary

OPD-SCAN, MODELS ARK-10000 AND ARK-9000 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Co., Ltd.. It received FDA 510(k) clearance on 2001-03-09 under 510(k) number K003299. The device is classified under product code HLQ. It was reviewed by the OP advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the OPD-SCAN, MODELS ARK-10000 AND ARK-9000?

OPD-SCAN, MODELS ARK-10000 AND ARK-9000 is a medical device that received FDA 510(k) clearance on 2001-03-09. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K003299.

When did OPD-SCAN, MODELS ARK-10000 AND ARK-9000 receive FDA 510(k) clearance?

OPD-SCAN, MODELS ARK-10000 AND ARK-9000 received FDA 510(k) clearance on 2001-03-09, under 510(k) number K003299.

Who is the listed applicant for OPD-SCAN, MODELS ARK-10000 AND ARK-9000?

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

What is the FDA product code for OPD-SCAN, MODELS ARK-10000 AND ARK-9000?

The FDA product code for OPD-SCAN, MODELS ARK-10000 AND ARK-9000 is HLQ.

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 Nidek 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.

K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXK203130Ophthalmic Yag Laser System YC-200K192045Ophthalmic Yag Laser System YC-200K190198Microperimeter MP-3, Microperimeter MP-3 Type SK181345Image Filing Software NAVIS-EXK173980Specular Microscope CEM-530

View all 17 devices →

Related Devices (Code: HLQ)

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.

K973756EYE SYS VISTAEyesys Technologies, Inc.K964290EYECHEKReichert Ophthalmic Instruments, Div. Leica, Inc.K945382TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.K944207TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.K944616KERATRON CORNEAL TOPOGRAPHERAlliance Medical MarketinigK940647ORBSCAN(TM) KERATOMETEROrbtek, Inc.

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.

↑