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FDA 510(k)

Physiotrace

K-Number: K171244 · 2017-08-23

ApplicantNimbleheart, Inc.
Decision Date2017-08-23
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Physiotrace is a medical device manufactured by Nimbleheart, Inc.. It received FDA 510(k) clearance on 2017-08-23 under approval number K171244. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Physiotrace?

Physiotrace is a medical device that received FDA 510(k) clearance on 2017-08-23. It is manufactured by Nimbleheart, Inc.. The 510(k) number is K171244.

When was Physiotrace approved by the FDA?

Physiotrace received FDA 510(k) clearance on 2017-08-23, under approval number K171244.

What company makes Physiotrace?

Physiotrace is manufactured by Nimbleheart, Inc..

What is the FDA product code for Physiotrace?

The FDA product code for Physiotrace is DRX.

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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