Spacelabs, Inc. - FDA 510(k) Cleared Devices

Spacelabs, Inc. is a medical device company based in McHenry, US. The company specializes in patient monitoring and diagnostic cardiology solutions.

Spacelabs received 46 FDA 510(k) clearances from 46 total submissions. The company's regulatory activity spans from 1976 to 1996, with Cardiovascular devices representing the dominant focus of its portfolio. This historical record reflects the company's early contributions to cardiac monitoring and anesthesiology device development.

Notable cleared devices include multigas analyzers, capnograph modules, patient care management systems, and defibrillator accessories. The company also developed information management and telemetry systems for clinical environments.

Explore the complete list of device names, product codes, and clearance dates in the database.