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FDA 510(k)

ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM

K-Number: K925705 · 1992-12-28

ApplicantDenar Corp.
Decision Date1992-12-28
Product CodeIWY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Denar Corp.. It received FDA 510(k) clearance on 1992-12-28 under 510(k) number K925705. 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 ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM?

ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-28. The listed applicant is Denar Corp.. The 510(k) number is K925705.

When did ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM receive FDA 510(k) clearance?

ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM received FDA 510(k) clearance on 1992-12-28, under 510(k) number K925705.

Who is the listed applicant for ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM?

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

What is the FDA product code for ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM?

The FDA product code for ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM 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 Denar Corp. 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.

K924759COLLIMATOR LIGHT SOURCEK884845STERI-OSSK883373STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANTK852802DENAR DENTAL IMPLANT

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.

K884493HEAD HOLDING DEVICE/SLEEP APNEAX-Ray SystemsK884847MTD HEDRESTComposites Horizons, Inc.K864527DUOCEPHGary E. Hall, DdsK850197KELLER 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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