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)

QUINTON Q-TE; RMS

K-Number: K041607 · 2004-07-16

ApplicantQuinton Cardiology, Inc.
Decision Date2004-07-16
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUINTON Q-TE; RMS is the device name listed in this FDA 510(k) record. The listed applicant is Quinton Cardiology, Inc.. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K041607. 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 QUINTON Q-TE; RMS?

QUINTON Q-TE; RMS is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Quinton Cardiology, Inc.. The 510(k) number is K041607.

When did QUINTON Q-TE; RMS receive FDA 510(k) clearance?

QUINTON Q-TE; RMS received FDA 510(k) clearance on 2004-07-16, under 510(k) number K041607.

Who is the listed applicant for QUINTON Q-TE; RMS?

The FDA 510(k) record lists Quinton Cardiology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUINTON Q-TE; RMS?

The FDA product code for QUINTON Q-TE; RMS 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

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.

↑