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FDA 510(k)

EYE FIXATION SPECULUM

K-Number: K964289 · 1996-12-17

ApplicantEyefix, Inc.
Decision Date1996-12-17
Product CodeHNC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE FIXATION SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Eyefix, Inc.. It received FDA 510(k) clearance on 1996-12-17 under 510(k) number K964289. The device is classified under product code HNC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE FIXATION SPECULUM?

EYE FIXATION SPECULUM is a medical device that received FDA 510(k) clearance on 1996-12-17. The listed applicant is Eyefix, Inc.. The 510(k) number is K964289.

When did EYE FIXATION SPECULUM receive FDA 510(k) clearance?

EYE FIXATION SPECULUM received FDA 510(k) clearance on 1996-12-17, under 510(k) number K964289.

Who is the listed applicant for EYE FIXATION SPECULUM?

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

What is the FDA product code for EYE FIXATION SPECULUM?

The FDA product code for EYE FIXATION SPECULUM is HNC.

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

Related Devices (Code: HNC)

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.

K022836STEPHENS DISPOSABLE SPECULUMStephens InstrumentsK981235OCULOSTATLaser Center Dev. Corp.K863989THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.K863664OPHTHALMIC SURGICAL SPECULUMMyocure, Inc.K843196VISITEC EYE SPECULUMVisitec Co.K830430EYELID SPECULUMDouglas C. Mckee & Co.

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.

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