Submission Details
| 510(k) Number | K212529 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 11, 2021 |
| Decision Date | November 23, 2021 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Hypotension Decision Assist Model HDA-OR2
Nov 2021
Decision
104d
Days
Class 2
Risk
About This 510(k) Submission
K212529 is an FDA 510(k) clearance for the Hypotension Decision Assist Model HDA-OR2, a Computer, Diagnostic, Pre-programmed, Single-function (Class II — Special Controls, product code DXG), submitted by Directed Systems, Ltd. (Cambridge, GB). The FDA issued a Cleared decision on November 23, 2021, 104 days after receiving the submission on August 11, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1435.
Device Classification
| Product Code | DXG — Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1435 |
Manufacturer
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