Hypotension Decision Assist— 510(k) K190955

Substantially Equivalent

Directed Systems, Ltd.

FDA 510(k) clearance K190955 for Hypotension Decision Assist, Substantially Equivalent on 2019-11-27. Applicant: Directed Systems, Ltd..

Clearance details

Applicant: Directed Systems, Ltd.
Product code: Code DXG
Advisory panel: Cardiovascular
Date received: 2019-04-11
Decision date: 2019-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.