Cleared Traditional

Hypotension Decision Assist

K190955 · Directed Systems, Ltd. · Cardiovascular

Nov 2019

Decision

230d

Days

Class 2

Risk

About This 510(k) Submission

K190955 is an FDA 510(k) clearance for the Hypotension Decision Assist, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Directed Systems, Ltd. (Cambridge, GB). The FDA issued a Cleared decision on November 27, 2019, 230 days after receiving the submission on April 11, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.

Submission Details

510(k) Number	K190955 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2019
Decision Date	November 27, 2019
Days to Decision	230 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF