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FDA 510(k)

DUOCEPH

K-Number: K864527 · 1987-01-07

ApplicantGary E. Hall, Dds
Decision Date1987-01-07
Product CodeIWY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUOCEPH is the device name listed in this FDA 510(k) record. The listed applicant is Gary E. Hall, Dds. It received FDA 510(k) clearance on 1987-01-07 under 510(k) number K864527. The device is classified under product code IWY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUOCEPH?

DUOCEPH is a medical device that received FDA 510(k) clearance on 1987-01-07. The listed applicant is Gary E. Hall, Dds. The 510(k) number is K864527.

When did DUOCEPH receive FDA 510(k) clearance?

DUOCEPH received FDA 510(k) clearance on 1987-01-07, under 510(k) number K864527.

Who is the listed applicant for DUOCEPH?

The FDA 510(k) record lists Gary E. Hall, Dds as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUOCEPH?

The FDA product code for DUOCEPH is IWY.

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 Gary E. Hall, Dds 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.

K840275CEHPALOMETRIC HEAD POSITIONER

Related Devices (Code: IWY)

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.

K925705ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMDenar Corp.K884493HEAD HOLDING DEVICE/SLEEP APNEAX-Ray SystemsK884847MTD HEDRESTComposites Horizons, Inc.K850197KELLER CEPHALOMETRIC DEVICEGary D. KellerK844549HEAD-SPINE STABILIZER HSS-1Imaging Accessories, Inc.K843340PORTA-STATPorta-Stat, 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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