Hypotension Decision Assist Model HDA-OR2— 510(k) K212529

Name: FDA 510(k) clearance K212529
Creator: U.S. Food and Drug Administration
Published: 2021-11-23

Substantially Equivalent

Directed Systems, Ltd.

FDA 510(k) clearance K212529 for Hypotension Decision Assist Model HDA-OR2, Substantially Equivalent on 2021-11-23. 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: 2021-08-11
Decision date: 2021-11-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

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