SENTEC, INC.

FDA Device Registration & Listing · Lincoln, RI, US · Registration 3012409105

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012409105
FEI Number
3012409105
Entity Name
SENTEC, INC.
City/State/Country
Lincoln, RI, US
Establishment Address
40 Albion Road, Suite 100, Lincoln, RI 02865, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Sentec, Inc. (Owner Number: 10051986)
Owner / Operator Contact Address
40 Albion Road, Suite 100, Lincoln, RI 02865, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K151329
PMA Number
N/A

All Registered Proprietary Names

Ear Clip Sentec Digital Monitoring System V-Sign Sensor 2 OxiVenT Sensor Sentec Digital Monitor Staysite Adhesive pad V-STATS PC software Multi-Site Attachment Rings

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia Anesthesiology Class 2 868.2500 2021-03-30
LPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia Anesthesiology Class 2 868.2500 2021-03-30
LKD Monitor, Carbon-Dioxide, Cutaneous Anesthesiology Class 2 868.2480 2021-03-30
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2021-03-30

Official Correspondent

Stephen Gorski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sentec, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K893133 Mennen Medical, Inc. HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX 1989-07-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012409105. Last updated year: 2026. Please use registration number 3012409105 when referencing this establishment in official correspondence.
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