4 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information.
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Ltd.·November 12, 2025
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Ltd.·December 25, 2024
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Ltd.·December 25, 2024
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Ltd.·December 16, 2020