Spacelabs Healthcare, Ltd.
Spacelabs Healthcare, Ltd. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2022, with 6 FDA device recalls on record.
Top product codes for Spacelabs Healthcare, Ltd.
FDA recalls by Spacelabs Healthcare, Ltd.
- 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-0684-2025 — Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
- Z-0685-2025 — 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.
- 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.
- Z-2589-2018 — Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
- Z-0072-2018 — Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Spacelabs Healthcare, Ltd.
- K212317 — Eclipse MINI Model 98900
- K211651 — Eclipse PRO
- K201921 — Spacelabs Lifescreen PRO Analyzer
- K152881 — SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
- K141113 — SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
- K130207 — SPACELABS HEALTHCARE CARDIOEXPRESS
- K110001 — SPACELABS PATHFINDER SL HOLTER ANALYZER
- K101850 — SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
- K103732 — SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.