Cleared Traditional

POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000

K844396 · Associated Mills, Inc. · Cardiovascular
Apr 1985
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K844396 is an FDA 510(k) clearance for the POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on April 18, 1985, 156 days after receiving the submission on November 13, 1984. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number K844396 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1984
Decision Date April 18, 1985
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

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
Endophys Blood Pressure Monitor
K160945 · Endophys Holdings, LLC · Sep 2016
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