Data / Medical devices / United States / Sentec, Inc.
Sentec, Inc.: FDA-registered device maker in Lincoln, RI, United States, 1 510(k) clearance
Sentec, Inc. is registered with the FDA (registration 3012409105) in Lincoln, RI, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 17, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012409105
- Address
- 40 Albion Road Suite 100, Lincoln, RI, United States, 02865
- Owner or operator
- Sentec, Inc. (10051986)
- Roles
- Complaint file establishment
- First device listed
- March 30, 2021
- Registered through
- 2026
- Brand names listed
- Ear Clip, Multi-Site Attachment Rings, OxiVenT Sensor, Sentec Digital Monitor, Sentec Digital Monitoring System, Staysite Adhesive pad, V-STATS PC software, V-Sign Sensor 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Carbon-Dioxide, Cutaneous | LKD | 2 | Complaint file establishment | accessdata.fda.gov |
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | 2 | Complaint file establishment | accessdata.fda.gov |
| Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | LPP | 2 | Complaint file establishment | accessdata.fda.gov |
| Oximeter, Ear | DPZ | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 17, 2015 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet | LKD | Substantially Equivalent | Sentec AG | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
- All makers of Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- All makers of Oximeter, Ear
- All makers of Monitor, Carbon-Dioxide, Cutaneous
Updated December 17, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.