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FDA 510(k)

SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)

K-Number: K112962 · 2011-11-02

ApplicantSpacelabs Medical, Inc.
Decision Date2011-11-02
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) 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 2011-11-02 under 510(k) number K112962. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)?

SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) is a medical device that received FDA 510(k) clearance on 2011-11-02. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K112962.

When did SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) receive FDA 510(k) clearance?

SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) received FDA 510(k) clearance on 2011-11-02, under 510(k) number K112962.

Who is the listed applicant for SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)?

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 HEALTHCARE XPREZZON BESIDE MONITOR(9913930)?

The FDA product code for SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) is MHX.

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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 (91390K102422SPACELABS MEDICAL PATIENT MONITORSK093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONK082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810K062095MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

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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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