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FDA 510(k)

B-Secur HeartKey Software Library

K-Number: K200884 · 2020-12-07

ApplicantB-Secur , Ltd.
Decision Date2020-12-07
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

B-Secur HeartKey Software Library is a medical device manufactured by B-Secur , Ltd.. It received FDA 510(k) clearance on 2020-12-07 under approval number K200884. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-Secur HeartKey Software Library?

B-Secur HeartKey Software Library is a medical device that received FDA 510(k) clearance on 2020-12-07. It is manufactured by B-Secur , Ltd.. The 510(k) number is K200884.

When was B-Secur HeartKey Software Library approved by the FDA?

B-Secur HeartKey Software Library received FDA 510(k) clearance on 2020-12-07, under approval number K200884.

What company makes B-Secur HeartKey Software Library?

B-Secur HeartKey Software Library is manufactured by B-Secur , Ltd..

What is the FDA product code for B-Secur HeartKey Software Library?

The FDA product code for B-Secur HeartKey Software Library is DPS.

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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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