SENTEC DIGITAL MONITOR MODEL #SDM
FDA 510(k) clearance K041548 · decided 2004-08-09
Clearance details
- K-number
- K041548
- Device name
- SENTEC DIGITAL MONITOR MODEL #SDM
- Applicant
- Sentec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-09
- Decision date
- 2004-08-09
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- LKD
- Device class
- 2
- Regulation number
- 868.2480
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Egale, WI, US
- 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 |
| V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS recall (Z-1980-2023) | SenTec AG | 2023-06-20 |
| SDMS (SenTec Digital Monitoring System) recall (Z-0088-2017) | SenTec AG | 2016-10-17 |