Cleared Traditional

ENDOPHYS BLOOD PRESSURE MONITOR

K141615 · Endophys, Inc. · Cardiovascular
Jan 2015
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K141615 is an FDA 510(k) clearance for the ENDOPHYS BLOOD PRESSURE MONITOR, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by Endophys, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 7, 2015, 205 days after receiving the submission on June 16, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number K141615 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2014
Decision Date January 07, 2015
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSK — Computer, Blood-pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1110

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