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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 a medical device manufactured by Biosig Technologies. It received FDA 510(k) clearance on 2018-08-08 under approval 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. It is manufactured by Biosig Technologies. The 510(k) number is K180805.

When was Pure EP approved by the FDA?

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

What company makes Pure EP?

Pure EP is manufactured by Biosig Technologies.

What is the FDA product code for Pure EP?

The FDA product code for Pure EP is DQK.

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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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