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

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..

Clearance details

Applicant
Directed Systems, Ltd.
Product code
Code DXG
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Cambridge, GB
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