Cleared Traditional

Sentec Digital Monitoring System (SDMS) tCOM+

K232516 · Sentec AG · Anesthesiology
May 2024
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K232516 is an FDA 510(k) clearance for the Sentec Digital Monitoring System (SDMS) tCOM+, 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 May 17, 2024, 273 days after receiving the submission on August 18, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2480.

Submission Details

510(k) Number K232516 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2023
Decision Date May 17, 2024
Days to Decision 273 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code LKD — Monitor, Carbon-dioxide, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2480

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