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FDA 510(k)

SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION

K-Number: K962811 · 1997-06-24

ApplicantSpacelabs Medical, Inc.
Decision Date1997-06-24
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION 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 1997-06-24 under 510(k) number K962811. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION?

SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K962811.

When did SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION receive FDA 510(k) clearance?

SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION received FDA 510(k) clearance on 1997-06-24, under 510(k) number K962811.

Who is the listed applicant for SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION?

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 MULTI-DISCLOSURE WORKSTATION?

The FDA product code for SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION is DXJ.

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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: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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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