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FDA 510(k)

SPACELABS MEDICAL MODEL 90481 EEG MODULE

K-Number: K932842 · 1994-03-02

ApplicantSpacelabs Medical, Inc.
Decision Date1994-03-02
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPACELABS MEDICAL MODEL 90481 EEG MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Medical, Inc.. It received FDA 510(k) clearance on 1994-03-02 under 510(k) number K932842. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS MEDICAL MODEL 90481 EEG MODULE?

SPACELABS MEDICAL MODEL 90481 EEG MODULE is a medical device that received FDA 510(k) clearance on 1994-03-02. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K932842.

When did SPACELABS MEDICAL MODEL 90481 EEG MODULE receive FDA 510(k) clearance?

SPACELABS MEDICAL MODEL 90481 EEG MODULE received FDA 510(k) clearance on 1994-03-02, under 510(k) number K932842.

Who is the listed applicant for SPACELABS MEDICAL MODEL 90481 EEG MODULE?

The FDA 510(k) record lists Spacelabs Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPACELABS MEDICAL MODEL 90481 EEG MODULE?

The FDA product code for SPACELABS MEDICAL MODEL 90481 EEG MODULE is GWQ.

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Other records listing Spacelabs Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)K102422SPACELABS MEDICAL PATIENT MONITORSK093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONK082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

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Related Devices (Code: GWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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