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FDA 510(k)

NeuTrace EP Mapping System v.2.1

K-Number: K233160 · 2023-11-25

ApplicantAnumana, Inc.
Decision Date2023-11-25
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NeuTrace EP Mapping System v.2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Anumana, Inc.. It received FDA 510(k) clearance on 2023-11-25 under 510(k) number K233160. 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 NeuTrace EP Mapping System v.2.1?

NeuTrace EP Mapping System v.2.1 is a medical device that received FDA 510(k) clearance on 2023-11-25. The listed applicant is Anumana, Inc.. The 510(k) number is K233160.

When did NeuTrace EP Mapping System v.2.1 receive FDA 510(k) clearance?

NeuTrace EP Mapping System v.2.1 received FDA 510(k) clearance on 2023-11-25, under 510(k) number K233160.

Who is the listed applicant for NeuTrace EP Mapping System v.2.1?

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

What is the FDA product code for NeuTrace EP Mapping System v.2.1?

The FDA product code for NeuTrace EP Mapping System v.2.1 is DQK.

Other records listing Anumana, 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.

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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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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