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FDA 510(k)

PUPIL PATHWAY ANALYZER (PPA)

K-Number: K895609 · 1989-11-02

ApplicantPulse Medical Instruments
Decision Date1989-11-02
Product CodeHLG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PUPIL PATHWAY ANALYZER (PPA) is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Medical Instruments. It received FDA 510(k) clearance on 1989-11-02 under 510(k) number K895609. The device is classified under product code HLG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUPIL PATHWAY ANALYZER (PPA)?

PUPIL PATHWAY ANALYZER (PPA) is a medical device that received FDA 510(k) clearance on 1989-11-02. The listed applicant is Pulse Medical Instruments. The 510(k) number is K895609.

When did PUPIL PATHWAY ANALYZER (PPA) receive FDA 510(k) clearance?

PUPIL PATHWAY ANALYZER (PPA) received FDA 510(k) clearance on 1989-11-02, under 510(k) number K895609.

Who is the listed applicant for PUPIL PATHWAY ANALYZER (PPA)?

The FDA 510(k) record lists Pulse Medical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUPIL PATHWAY ANALYZER (PPA)?

The FDA product code for PUPIL PATHWAY ANALYZER (PPA) is HLG.

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: HLG)

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.

K920937COMPUTERIZED PUPILTrek Medical Products, Inc.K802351F110 PHOTO BINOCULAR OPHTHALMOSCOPEMinami, Tomine & Lew

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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