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FDA 510(k)

MODIFICATION TO EDI VERIS SYSTEM

K-Number: K003442 · 2001-05-04

ApplicantElectro-Diagnostic Imaging, Inc.
Decision Date2001-05-04
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EDI VERIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Diagnostic Imaging, Inc.. It received FDA 510(k) clearance on 2001-05-04 under 510(k) number K003442. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO EDI VERIS SYSTEM?

MODIFICATION TO EDI VERIS SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-04. The listed applicant is Electro-Diagnostic Imaging, Inc.. The 510(k) number is K003442.

When did MODIFICATION TO EDI VERIS SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO EDI VERIS SYSTEM received FDA 510(k) clearance on 2001-05-04, under 510(k) number K003442.

Who is the listed applicant for MODIFICATION TO EDI VERIS SYSTEM?

The FDA 510(k) record lists Electro-Diagnostic Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO EDI VERIS SYSTEM?

The FDA product code for MODIFICATION TO EDI VERIS SYSTEM is HLX.

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 Electro-Diagnostic Imaging, Inc. 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.

K983983EDI VERIS SYSTEM

Related Devices (Code: HLX)

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.

K983983EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K925741CLARUS ENDOSCOPIC HOOK KNIFEClarus Medical Systems, Inc.K914393RETINA TESTERRetina TesterK914163SCOPTOPIC SENSITIVITY TEST-1[SST-1]Lkc Technologies, Inc.K873990IRAS EDS INTERFEROMETRIC STIMULATORRandwal Instrument Co., Inc.K853812PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)Biosan Laboratories, 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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