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FDA 510(k)

LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE

K-Number: K101331 · 2010-10-08

ApplicantC.R. Bard Inc., Bard Electrophysiology Division
Decision Date2010-10-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE 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 2010-10-08 under 510(k) number K101331. 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 LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE?

LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE is a medical device that received FDA 510(k) clearance on 2010-10-08. The listed applicant is C.R. Bard Inc., Bard Electrophysiology Division. The 510(k) number is K101331.

When did LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE receive FDA 510(k) clearance?

LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE received FDA 510(k) clearance on 2010-10-08, under 510(k) number K101331.

Who is the listed applicant for LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE?

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 LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE?

The FDA product code for LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE 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.

K113811V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEMK082094BARD 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

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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