Cleared Traditional

SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet

K151329 · Sentec AG · Anesthesiology

Dec 2015

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K151329 is an FDA 510(k) clearance for the SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet, a Monitor, Carbon-dioxide, Cutaneous (Class II — Special Controls, product code LKD), submitted by Sentec AG (Therwil, CH). The FDA issued a Cleared decision on December 17, 2015, 213 days after receiving the submission on May 18, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2480.

Submission Details

510(k) Number	K151329 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2015
Decision Date	December 17, 2015
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF