Spacelabs, Inc.
United StatesFDA applicant, unverified
- Devices
- 46
What Spacelabs, Inc. makes
Spacelabs, Inc. manufactures cardiac monitoring devices, including ECG recorders (such as the HeartRate Plus ECG Cardule #1918 and Pulse Cardule models 1859/1860), patient monitors (Series 700, Series 90700, and Series 1000), and specialized modules for cardiac output and venous oxygen saturation. The company also produces systems for arrhythmia analysis (ArrhythmiaNET Level 2) and data interfacing (FlexPort Interface, General System Link). Multigas analyzers (Model 90514) and patient care management software modifications are part of its portfolio.
These devices are classified under FDA regulations as Class I or Class II, with submissions recorded in the FDA’s 510(k) clearance database. The company’s products are listed in the US under the jurisdiction of the FDA, adhering to applicable medical device regulations.
Catalogue
Search and filter all 46 devicesFrequently asked questions
How many devices does Spacelabs, Inc. have in the registry?
The registry currently lists 46 devices for Spacelabs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spacelabs, Inc.'s devices?
Among its 46 most recently registered devices, Spacelabs, Inc. has devices listed in FDA 510(k) (46 devices).
What risk classes do Spacelabs, Inc.'s devices fall under?
Among its 46 most recently registered devices, the classes recorded for Spacelabs, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spacelabs, Inc. in the registry?
The most recently registered devices listed for Spacelabs, Inc. include HEARTRATE PLUS ECG CARDULE #1918, SPACELABS SERIES 1000, SPACELABS SERIES 90700 PATIENT MONITORS and SPACELABS-GENERAL SYSTEM LINK.