Sentec Digital Monitoring System (SDMS) tCOM+— 510(k) K232516

Name: FDA 510(k) clearance K232516
Creator: U.S. Food and Drug Administration
Published: 2024-05-17

Substantially Equivalent

Sentec AG

FDA 510(k) clearance K232516 for Sentec Digital Monitoring System (SDMS) tCOM+, Substantially Equivalent on 2024-05-17. Applicant: Sentec AG. Device class: 2.

Clearance details

Applicant: Sentec AG
Product code: Code LKD
Device class: Class 2
Regulation: 21 CFR 868.2480
Advisory panel: Anesthesiology
Date received: 2023-08-18
Decision date: 2024-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Therwil, CH

Download summary PDF View on FDA.gov ↗

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