Physiotrace
K-Number: K171244 · 2017-08-23
ApplicantNimbleheart, Inc.
Decision Date2017-08-23
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Physiotrace is the device name listed in this FDA 510(k) record. The listed applicant is Nimbleheart, Inc.. It received FDA 510(k) clearance on 2017-08-23 under 510(k) 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. The listed applicant is Nimbleheart, Inc.. The 510(k) number is K171244.
When did Physiotrace receive FDA 510(k) clearance?
Physiotrace received FDA 510(k) clearance on 2017-08-23, under 510(k) number K171244.
Who is the listed applicant for Physiotrace?
The FDA 510(k) record lists Nimbleheart, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.