Hypotension Decision Assist— 510(k) K190955

Name: FDA 510(k) clearance K190955
Creator: U.S. Food and Drug Administration
Published: 2019-11-27

Substantially Equivalent

Directed Systems, Ltd.

FDA 510(k) clearance K190955 for Hypotension Decision Assist, Substantially Equivalent on 2019-11-27. Applicant: Directed Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Directed Systems, Ltd.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
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 ↗

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