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)

M4 MONITOR

K-Number: K110957 · 2011-05-31

ApplicantSpectrum Medical, Llp
Decision Date2011-05-31
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M4 MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical, Llp. It received FDA 510(k) clearance on 2011-05-31 under 510(k) number K110957. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M4 MONITOR?

M4 MONITOR is a medical device that received FDA 510(k) clearance on 2011-05-31. The listed applicant is Spectrum Medical, Llp. The 510(k) number is K110957.

When did M4 MONITOR receive FDA 510(k) clearance?

M4 MONITOR received FDA 510(k) clearance on 2011-05-31, under 510(k) number K110957.

Who is the listed applicant for M4 MONITOR?

The FDA 510(k) record lists Spectrum Medical, Llp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M4 MONITOR?

The FDA product code for M4 MONITOR is DRY.

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 Spectrum Medical, Llp 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.

K062468SPECTRUM M2 MONITOR

Related Devices (Code: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.

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.

↑