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FDA 510(k)

Pure EP

K-Number: K180805 · 2018-08-08

ApplicantBiosig Technologies
Decision Date2018-08-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pure EP is the device name listed in this FDA 510(k) record. The listed applicant is Biosig Technologies. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K180805. 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 Pure EP?

Pure EP is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Biosig Technologies. The 510(k) number is K180805.

When did Pure EP receive FDA 510(k) clearance?

Pure EP received FDA 510(k) clearance on 2018-08-08, under 510(k) number K180805.

Who is the listed applicant for Pure EP?

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

What is the FDA product code for Pure EP?

The FDA product code for Pure EP is DQK.

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

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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