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FDA 510(k)

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300

K-Number: K911615 · 1992-01-08

ApplicantDiagnostic Monitoring Software
Decision Date1992-01-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Monitoring Software. It received FDA 510(k) clearance on 1992-01-08 under 510(k) number K911615. 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 HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300?

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 is a medical device that received FDA 510(k) clearance on 1992-01-08. The listed applicant is Diagnostic Monitoring Software. The 510(k) number is K911615.

When did HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 receive FDA 510(k) clearance?

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 received FDA 510(k) clearance on 1992-01-08, under 510(k) number K911615.

Who is the listed applicant for HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300?

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

What is the FDA product code for HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300?

The FDA product code for HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 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 Diagnostic Monitoring Software 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.

K062959DMS 300-2, 300-3 AND 300-4K062088PREMIER 11 HOLTERK062007DMS 300-7

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.

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