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FDA 510(k)

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

K-Number: K071348 · 2007-09-07

ApplicantMennen Medical , Ltd.
Decision Date2007-09-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical , Ltd.. It received FDA 510(k) clearance on 2007-09-07 under 510(k) number K071348. 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 EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM?

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-07. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K071348.

When did EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM receive FDA 510(k) clearance?

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM received FDA 510(k) clearance on 2007-09-07, under 510(k) number K071348.

Who is the listed applicant for EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM?

The FDA 510(k) record lists Mennen Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM?

The FDA product code for EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM is DQK.

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Other records listing Mennen Medical , Ltd. 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.

K131789CEREBRALOGIK- AEEGK123792HORIZON XVU (FFR)K093766VITALOGIK 6000/6500K091165HORIZON XVUK083063BIS INTERFACE FOR VITALOGIK PATIENT MONITORSK081484HORIZON XVU

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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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