The following data is part of a premarket notification filed by Directed Systems Ltd with the FDA for Hypotension Decision Assist.
| Device ID | K190955 |
| 510k Number | K190955 |
| Device Name: | Hypotension Decision Assist |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | Directed Systems Ltd St John's Innovation Centre, Cowley Road Cambridge, GB Cb4 0ws |
| Contact | Mark S. Leaning |
| Correspondent | Mark S. Leaning Directed Systems Ltd St John's Innovation Centre, Cowley Road Cambridge, GB Cb4 0ws |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-11 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003496701 | K190955 | 000 |