Cleared Traditional

Physiotrace

K171244 · Nimbleheart, Inc. · Cardiovascular
Aug 2017
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K171244 is an FDA 510(k) clearance for the Physiotrace, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Nimbleheart, Inc. (Campbell, US). The FDA issued a Cleared decision on August 23, 2017, 117 days after receiving the submission on April 28, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K171244 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2017
Decision Date August 23, 2017
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRX — Electrode, Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2360

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