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FDA 510(k)

ADVANTAGE EP

K-Number: K903734 · 1991-07-22

ApplicantClark Davis Medical Systems, Inc.
Decision Date1991-07-22
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE EP is the device name listed in this FDA 510(k) record. The listed applicant is Clark Davis Medical Systems, Inc.. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K903734. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTAGE EP?

ADVANTAGE EP is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is Clark Davis Medical Systems, Inc.. The 510(k) number is K903734.

When did ADVANTAGE EP receive FDA 510(k) clearance?

ADVANTAGE EP received FDA 510(k) clearance on 1991-07-22, under 510(k) number K903734.

Who is the listed applicant for ADVANTAGE EP?

The FDA 510(k) record lists Clark Davis Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTAGE EP?

The FDA product code for ADVANTAGE EP is GWE.

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 Clark Davis Medical Systems, 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.

K885246ADVANTAGE

Related Devices (Code: GWE)

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.

K221471E3 and ProfileDiagnosys, LLCK212936Vision Monitor- MonCvONEMetrovisionK211974LED PHOTIC SystemMicromed S.P.A.K211643Vision Monitor - MonpackONEMetrovisionK200705Nurochek SystemCryptych Pty, Ltd.K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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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