Cleared Traditional

K170032 - QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
(FDA 510(k) Clearance)

K170032 · Fysicon BV · Cardiovascular

Sep 2017

Decision

247d

Days

Class 2

Risk

K170032 is an FDA 510(k) clearance for the QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI).

Submitted by Fysicon BV (Oss, NL). The FDA issued a Cleared decision on September 8, 2017, 247 days after receiving the submission on January 4, 2017.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K170032 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 2017
Decision Date	September 08, 2017
Days to Decision	247 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300