The following data is part of a premarket notification filed by Directed Systems Ltd with the FDA for Hypotension Decision Assist Model Hda-or2.
| Device ID | K212529 |
| 510k Number | K212529 |
| Device Name: | Hypotension Decision Assist Model HDA-OR2 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | Directed Systems Ltd 47-51 Norfolk Street Cambridge, GB Cb1 2ld |
| Contact | Mark S. Leaning |
| Correspondent | Mark S. Leaning Directed Systems Ltd 47-51 Norfolk Street Cambridge, GB Cb1 2ld |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-11 |
| Decision Date | 2021-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003496718 | K212529 | 000 |