FDA Registration
Active
🇺🇸 United States
V-Sign Sensor 2
Reg #: 3012409105
·
FEI: 3012409105
·
Expires 2025
Products
4
Proprietary Names
8
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SENTEC, INC.
- Registration Number
- 3012409105
- FEI Number
- 3012409105
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 40 Albion Road, Suite 100
- City
- Lincoln
- State
- RI
- ZIP
- 02865
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151329
Owner / Operator
- Firm Name
- Sentec, Inc.
- Operator Number
- 10051986
- Address
- 40 Albion Road, Suite 100
- City
- Lincoln
- State
- RI
- Postal Code
- 02865
- Country
- US
- Correspondent
- Stephen H Gorski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Carbon-Dioxide, Cutaneous | LKD | Class 2 | Anesthesiology | No | 2021-03-30 |
| Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | LPP | Class 2 | Anesthesiology | No | 2021-03-30 |
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | Class 2 | Anesthesiology | No | 2021-03-30 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2021-03-30 |
Proprietary Names
V-Sign Sensor 2
OxiVenT Sensor
V-STATS PC software
Multi-Site Attachment Rings
Ear Clip
Staysite Adhesive pad
Sentec Digital Monitoring System
Sentec Digital Monitor
Establishment Types
Complaint File Establishment per 21 CFR 820.198