SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
FDA 510(k) clearance K151329 · decided 2015-12-17
Clearance details
- K-number
- K151329
- Device name
- SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
- Applicant
- Sentec AG
- Decision
- Substantially Equivalent
- Date received
- 2015-05-18
- Decision date
- 2015-12-17
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- LKD
- Device class
- 2
- Regulation number
- 868.2480
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Therwil, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Re recall (Z-2592-2023) | SenTec AG | 2023-09-15 |
| sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in recall (Z-0148-2023) | SenTec AG | 2022-10-28 |
| SDMS (SenTec Digital Monitoring System) recall (Z-0088-2017) | SenTec AG | 2016-10-17 |