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)

NIDEK RS-3000

K-Number: K121622 · 2013-03-14

ApplicantNidek Co., Ltd.
Decision Date2013-03-14
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK RS-3000 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 2013-03-14 under 510(k) number K121622. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK RS-3000?

NIDEK RS-3000 is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K121622.

When did NIDEK RS-3000 receive FDA 510(k) clearance?

NIDEK RS-3000 received FDA 510(k) clearance on 2013-03-14, under 510(k) number K121622.

Who is the listed applicant for NIDEK RS-3000?

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 NIDEK RS-3000?

The FDA product code for NIDEK RS-3000 is OBO.

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: OBO)

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.

K261019ANTERIONHeidelberg Engineering GmbHK253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbH

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.

↑