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
FDA 510(k) clearance K171751 · decided 2017-10-24
Clearance details
- K-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
- Applicant
- Capsule Technologie Sas
- Decision
- Substantially Equivalent
- Date received
- 2017-06-13
- Decision date
- 2017-10-24
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K242737) | Empatica S.r.l. | 2025-06-06 |
| WARD-CSS (v1.2.x) (K241958) | Ward 24/7 Aps | 2025-02-14 |
| iCare APP (K243146) | Ihealth Labs, Inc. | 2025-02-03 |
| Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (K241411) | Welch Allyn, Inc. | 2024-12-20 |
| Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (K243216) | Analog Devices | 2024-12-10 |
| AMC Health CareConsole (K233446) | Amc Health | 2024-09-27 |
| Happy Ring Health Monitoring System (K240236) | Happy Health, Inc. | 2024-09-24 |
| WVSM Pro (Series) (500-0030-XX) (K233354) | Athena Gtx, Inc. | 2024-06-26 |
Recalls involving this device
No recalls on record reference this clearance.