Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IQMARK DIGITAL HOLTER

K-Number: K031466 · 2003-06-11

ApplicantBrentwood Medical Technology Corp.
Decision Date2003-06-11
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IQMARK DIGITAL HOLTER is the device name listed in this FDA 510(k) record. The listed applicant is Brentwood Medical Technology Corp.. It received FDA 510(k) clearance on 2003-06-11 under 510(k) number K031466. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQMARK DIGITAL HOLTER?

IQMARK DIGITAL HOLTER is a medical device that received FDA 510(k) clearance on 2003-06-11. The listed applicant is Brentwood Medical Technology Corp.. The 510(k) number is K031466.

When did IQMARK DIGITAL HOLTER receive FDA 510(k) clearance?

IQMARK DIGITAL HOLTER received FDA 510(k) clearance on 2003-06-11, under 510(k) number K031466.

Who is the listed applicant for IQMARK DIGITAL HOLTER?

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

What is the FDA product code for IQMARK DIGITAL HOLTER?

The FDA product code for IQMARK DIGITAL HOLTER is MLO.

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 Brentwood Medical Technology 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.

K103640MIDMARK IQECGK100913IQVITALS AND IQVITALS SYSTEMK052898IQMARK EZ STRESSK013717BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARYK010505TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARYK002499BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE

View all 7 devices →

Related Devices (Code: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

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.

↑