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FDA 510(k)

ENSITE SYSTEM, MODEL EE3000

K-Number: K042493 · 2004-10-15

ApplicantEndocardial Solutions, Inc.
Decision Date2004-10-15
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENSITE SYSTEM, MODEL EE3000 is the device name listed in this FDA 510(k) record. The listed applicant is Endocardial Solutions, Inc.. It received FDA 510(k) clearance on 2004-10-15 under 510(k) number K042493. 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 ENSITE SYSTEM, MODEL EE3000?

ENSITE SYSTEM, MODEL EE3000 is a medical device that received FDA 510(k) clearance on 2004-10-15. The listed applicant is Endocardial Solutions, Inc.. The 510(k) number is K042493.

When did ENSITE SYSTEM, MODEL EE3000 receive FDA 510(k) clearance?

ENSITE SYSTEM, MODEL EE3000 received FDA 510(k) clearance on 2004-10-15, under 510(k) number K042493.

Who is the listed applicant for ENSITE SYSTEM, MODEL EE3000?

The FDA 510(k) record lists Endocardial Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENSITE SYSTEM, MODEL EE3000?

The FDA product code for ENSITE SYSTEM, MODEL EE3000 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.

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Other records listing Endocardial Solutions, Inc. 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.

K033211ENSITE SYSTEMK030129MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000K012926MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000K001437ENSITE 3000 SYSTEM, MODEL EE3000K993376ENSTYLET MODELS EC0010, EC0020K992479ENSITE 3000 SYSTEM

View all 8 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.

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