SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM— 510(k) K152881
Substantially EquivalentSpacelabs Healthcare, Ltd.
FDA 510(k) clearance K152881 for SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM, Substantially Equivalent on 2016-04-01. Applicant: Spacelabs Healthcare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Spacelabs Healthcare, Ltd.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hertford, GB
Recent devices under product code DQK
view allMore clearances from Spacelabs Healthcare, Ltd.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K152881
K-number listed on FDA's recall record- Z-0416-2026 — 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.
- Z-0563-2021 — Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152881.
Data sourced from openFDA. This site is unofficial and independent of the FDA.