Cleared Traditional

Endophys Blood Pressure Monitor

K160945 · Endophys Holdings, LLC · Cardiovascular
Sep 2016
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K160945 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 Holdings, LLC (Dallas, US). The FDA issued a Cleared decision on September 26, 2016, 174 days after receiving the submission on April 5, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number K160945 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2016
Decision Date September 26, 2016
Days to Decision 174 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

Similar Devices — DSK Computer, Blood-pressure

All 76
Endophys Blood Pressure Monitor model BPM-30
K231586 · Endophys Technologies, LLC · Nov 2023
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · Volcano Corporation · Dec 2015
ENDOPHYS BLOOD PRESSURE MONITOR
K141615 · Endophys, Inc. · Jan 2015
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
K080670 · Atcor Medical · Apr 2008
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
K070795 · Atcor Medical Pty, Ltd. · Aug 2007
MONITORING SYSTEM, MODEL ARGUS PB-2200
K033738 · Schiller AG · Aug 2004