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FDA 510(k)

MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

K-Number: K082045 · 2008-08-01

ApplicantSpacelabs Medical, Inc.
Decision Date2008-08-01
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 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 2008-08-01 under 510(k) number K082045. 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 MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220?

MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 is a medical device that received FDA 510(k) clearance on 2008-08-01. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K082045.

When did MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 receive FDA 510(k) clearance?

MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 received FDA 510(k) clearance on 2008-08-01, under 510(k) number K082045.

Who is the listed applicant for MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220?

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 MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220?

The FDA product code for MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 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 MONITORSK093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONK063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810K062095MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

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Related Devices (Code: MHX)

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.

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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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