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FDA 510(k)

V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

K-Number: K113811 · 2012-03-16

ApplicantC.R. Bard Inc., Bard Electrophysiology Division
Decision Date2012-03-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard Inc., Bard Electrophysiology Division. It received FDA 510(k) clearance on 2012-03-16 under 510(k) number K113811. 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 V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM?

V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is C.R. Bard Inc., Bard Electrophysiology Division. The 510(k) number is K113811.

When did V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM receive FDA 510(k) clearance?

V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM received FDA 510(k) clearance on 2012-03-16, under 510(k) number K113811.

Who is the listed applicant for V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM?

The FDA 510(k) record lists C.R. Bard Inc., Bard Electrophysiology Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM?

The FDA product code for V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP 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 C.R. Bard Inc., Bard Electrophysiology Division 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.

K101331LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWAREK082094BARD PTFE (TEFLON) COATED GUIDE WIRES

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

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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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