Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

K-Number: K062095 · 2006-09-29

ApplicantSpacelabs Medical, Inc.
Decision Date2006-09-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 2006-09-29 under 510(k) number K062095. 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 MCARE 300 VITAL SIGNS MONITOR, MODEL 91220?

MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 is a medical device that received FDA 510(k) clearance on 2006-09-29. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K062095.

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

MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 received FDA 510(k) clearance on 2006-09-29, under 510(k) number K062095.

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

The FDA product code for MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 is MHX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 35 devices →

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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.

↑