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)

AMBULATORY (HOLTER) RECORDING SYSTEM

K-Number: K950723 · 1996-02-09

ApplicantBiosensor Corp.
Decision Date1996-02-09
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBULATORY (HOLTER) RECORDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosensor Corp.. It received FDA 510(k) clearance on 1996-02-09 under 510(k) number K950723. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULATORY (HOLTER) RECORDING SYSTEM?

AMBULATORY (HOLTER) RECORDING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Biosensor Corp.. The 510(k) number is K950723.

When did AMBULATORY (HOLTER) RECORDING SYSTEM receive FDA 510(k) clearance?

AMBULATORY (HOLTER) RECORDING SYSTEM received FDA 510(k) clearance on 1996-02-09, under 510(k) number K950723.

Who is the listed applicant for AMBULATORY (HOLTER) RECORDING SYSTEM?

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

What is the FDA product code for AMBULATORY (HOLTER) RECORDING SYSTEM?

The FDA product code for AMBULATORY (HOLTER) RECORDING SYSTEM is DQK.

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 Biosensor 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.

K990956BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005K974546BIOSENSOR HOLTER MONITOR SYSTEMK974192BIOSENSOR HOLTER MONITOR SYSTEMK950944AMBULATORY (HOLTER) RECORDING SYSTEMK960449PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)K943338BIOSENSOR BIDOP VASCULAR TEST SYSTEM

View all 10 devices →

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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.

↑