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510(k) K212529

Hypotension Decision Assist Model HDA-OR2 by Directed Systems, Ltd. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2021
Date Received
August 11, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Directed Systems, Ltd.

  • K190955 — Hypotension Decision Assist (November 27, 2019)

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