SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
FDA 510(k) clearance K101690 · decided 2010-12-03
Clearance details
- K-number
- K101690
- Device name
- SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
- Applicant
- Sentec AG
- Decision
- Substantially Equivalent
- Date received
- 2010-06-16
- Decision date
- 2010-12-03
- Days to decision
- 170 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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