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FDA 510(k)

ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION

K-Number: K093501 · 2009-11-24

ApplicantSpacelabs Medical, Inc.
Decision Date2009-11-24
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION 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 2009-11-24 under 510(k) number K093501. 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 ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION?

ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K093501.

When did ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION receive FDA 510(k) clearance?

ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION received FDA 510(k) clearance on 2009-11-24, under 510(k) number K093501.

Who is the listed applicant for ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION?

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 ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION?

The FDA product code for ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION 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 (91390K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)K102422SPACELABS MEDICAL PATIENT MONITORSK082045MODIFICATION 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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