The following data is part of a premarket notification filed by Capsule Technologie with the FDA for Smartlinx Vitals Plus Patient Monitoring System.
| Device ID | K183638 |
| 510k Number | K183638 |
| Device Name: | SmartLinx Vitals Plus Patient Monitoring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Capsule Technologie 300 Brickstone Square, Suite 203 Andover, MA 01810 |
| Contact | Maylin Truesdell |
| Correspondent | Maylin Truesdell Capsule Technologie 300 Brickstone Square, Suite 203 Andover, MA 01810 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-04-17 |