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FDA 510(k)

AUTOPOLE REGULATOR SYSTEM

K-Number: K924999 · 1992-12-24

ApplicantEscalon Trek Medical
Decision Date1992-12-24
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOPOLE REGULATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Escalon Trek Medical. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K924999. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOPOLE REGULATOR SYSTEM?

AUTOPOLE REGULATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Escalon Trek Medical. The 510(k) number is K924999.

When did AUTOPOLE REGULATOR SYSTEM receive FDA 510(k) clearance?

AUTOPOLE REGULATOR SYSTEM received FDA 510(k) clearance on 1992-12-24, under 510(k) number K924999.

Who is the listed applicant for AUTOPOLE REGULATOR SYSTEM?

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

What is the FDA product code for AUTOPOLE REGULATOR SYSTEM?

The FDA product code for AUTOPOLE REGULATOR SYSTEM is KYG.

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 Escalon Trek Medical 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.

K963417VITLITE (TR7700)K963434VISCOUS FLUID SYSTEM

Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.

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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