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)

NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H

K-Number: K942713 · 1994-08-05

ApplicantNeitz Instruments Company, Ltd.
Decision Date1994-08-05
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H is the device name listed in this FDA 510(k) record. The listed applicant is Neitz Instruments Company, Ltd.. It received FDA 510(k) clearance on 1994-08-05 under 510(k) number K942713. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H?

NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H is a medical device that received FDA 510(k) clearance on 1994-08-05. The listed applicant is Neitz Instruments Company, Ltd.. The 510(k) number is K942713.

When did NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H receive FDA 510(k) clearance?

NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H received FDA 510(k) clearance on 1994-08-05, under 510(k) number K942713.

Who is the listed applicant for NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H?

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

What is the FDA product code for NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H?

The FDA product code for NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H is HLI.

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 Neitz Instruments Company, 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.

K972440CATARACTSCREENER CT - SK951341NEITZ SLIT LAMP SL-H2K951337FIBER HEAD LIGHT FH-300K950788OTOSCOPE A-34K951340NEITZ SLIT LAMP SL-H1K951338INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV

View all 24 devices →

Related Devices (Code: HLI)

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.

K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KGK121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.

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.

↑