The following data is part of a premarket notification filed by Capsule Technologie, Sas with the FDA for Smartlinx Vitals Plus Nibp Module, Smartlinx Vitals Plus License For Spot Monitoring Mode, Smartlinx Vitals Plus Alarm Hub, Smartlinx Vitals Plus License For Advanced Monitoring Mode, Covidien Filac 3000 - Temperature Module.
| Device ID | K171751 |
| 510k Number | K171751 |
| Device Name: | SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License For Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License For Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Capsule Technologie, SAS 300 Brickstone Square Andover, MA 01810 |
| Contact | James Hodge |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-06-13 |
| Decision Date | 2017-10-24 |
| Summary: | summary |