FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
K Number: K101690
·
Decision Dec 3, 2010
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
16
Applicant Total
3
Review Days
170
Basic Information
- Device Name
- SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
- K Number
- K101690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2480
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SENTEC AG
- Date Received
- June 16, 2010
- Decision Date
- December 3, 2010
- Product Code
- LKD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKD | Monitor, Carbon-Dioxide, Cutaneous | FDA class 2 | Anesthesiology |
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