510(k) K152881 ยท DQK Computer, Diagnostic, Programmable
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
| Applicant | Spacelabs Healthcare, Ltd., Hertford, GB |
| Decision | Substantially Equivalent, Apr 1, 2016 |
| Received | Sep 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2025 | Spacelabs Healthcare, Ltd. 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 Cardi Open, Classified |
DQK | None listed |
| Nov 6, 2020 | Spacelabs Healthcare, Ltd. Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use. Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.