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FDA 510(k)

PUPILSCAN

K-Number: K854169 · 1985-12-16

ApplicantFairville Medical Optics, Inc.
Decision Date1985-12-16
Product Code
DecisionSubstantially Equivalent

Device Summary

PUPILSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Fairville Medical Optics, Inc.. It received FDA 510(k) clearance on 1985-12-16 under 510(k) number K854169. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUPILSCAN?

PUPILSCAN is a medical device that received FDA 510(k) clearance on 1985-12-16. The listed applicant is Fairville Medical Optics, Inc.. The 510(k) number is K854169.

When did PUPILSCAN receive FDA 510(k) clearance?

PUPILSCAN received FDA 510(k) clearance on 1985-12-16, under 510(k) number K854169.

Who is the listed applicant for PUPILSCAN?

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

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

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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