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FDA 510(k)

POLARON

K-Number: K902187 · 1990-08-08

ApplicantNurion Industries
Decision Date1990-08-08
Product CodeHPG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

POLARON is the device name listed in this FDA 510(k) record. The listed applicant is Nurion Industries. It received FDA 510(k) clearance on 1990-08-08 under 510(k) number K902187. The device is classified under product code HPG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARON?

POLARON is a medical device that received FDA 510(k) clearance on 1990-08-08. The listed applicant is Nurion Industries. The 510(k) number is K902187.

When did POLARON receive FDA 510(k) clearance?

POLARON received FDA 510(k) clearance on 1990-08-08, under 510(k) number K902187.

Who is the listed applicant for POLARON?

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

What is the FDA product code for POLARON?

The FDA product code for POLARON is HPG.

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 Nurion Industries 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.

K910601PATHFINDERK903558LASER CANE

Related Devices (Code: HPG)

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.

K910601PATHFINDERNurion IndustriesK910124LOW VISION ENHANCEMENT SYSTEM (LVES)Triangle InvestmentsK903558LASER CANENurion IndustriesK862338SENSORY 6Brytech, Inc.K823385ALESOmsK761215F4912 NIGHT VISION AIDItt Corp.

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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