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Spacelabs Medical, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
35
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Spacelabs Medical, Inc. makes

Spacelabs Medical, Inc. manufactures patient monitoring systems and related modules, including ECG modules, EEG modules, bispectral index analysis modules, multiparameter modules, vital signs monitors, and full disclosure systems. Specific products include the Model 90481 EEG module, Model 90492 ECG module, Model 91482 BISx analysis module with accessories Model 91842, Model 91810 full disclosure system, Qube compact monitor (Model 91390), and various patient monitors and integrated modules such as Model 91496 and Model 90496.

The devices listed are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue35

Newest first, rows 1-35 of 35

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Rows 1-35 of 35

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Spacelabs Medical, Inc., initiated on 2004-05-07. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2004

    • 7 May 2004 Z-1007-04 Unclassified (pre-2012) Terminated Potential for telemetry channels to drop off display. Distribution: The firm distributes to hospitals nationwide. The firm also distributes to distributors internationally.
    • 7 May 2004 Z-1008-04 Unclassified (pre-2012) Terminated Potential for telemetry channels to drop off display. Distribution: The firm distributes to hospitals nationwide. The firm also distributes to distributors internationally.

Frequently asked questions

How many devices does Spacelabs Medical, Inc. have in the registry?

The registry currently lists 35 devices for Spacelabs Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Spacelabs Medical, Inc.'s devices?

Among its 35 most recently registered devices, Spacelabs Medical, Inc. has devices listed in FDA 510(k) (35 devices).

What risk classes do Spacelabs Medical, Inc.'s devices fall under?

Among its 35 most recently registered devices, the classes recorded for Spacelabs Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Spacelabs Medical, Inc.?

FDA recall records list 2 recalls initiated by Spacelabs Medical, Inc., the most recent initiated on 2004-05-07. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Spacelabs Medical, Inc. in the registry?

The most recently registered devices listed for Spacelabs Medical, Inc. include SPACELABS MEDICAL MODEL 90481 EEG MODULE, SPACELABS MEDICAL ECG MODULE (MODEL 90492), SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 and SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810.

Generated automatically from registry data and not verified by a human reviewer.