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)

INRATIO 2 PT MONITORING SYSTEM

K-Number: K072727 · 2007-10-26

ApplicantHemosense, Inc.
Decision Date2007-10-26
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INRATIO 2 PT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemosense, Inc.. It received FDA 510(k) clearance on 2007-10-26 under 510(k) number K072727. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INRATIO 2 PT MONITORING SYSTEM?

INRATIO 2 PT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-26. The listed applicant is Hemosense, Inc.. The 510(k) number is K072727.

When did INRATIO 2 PT MONITORING SYSTEM receive FDA 510(k) clearance?

INRATIO 2 PT MONITORING SYSTEM received FDA 510(k) clearance on 2007-10-26, under 510(k) number K072727.

Who is the listed applicant for INRATIO 2 PT MONITORING SYSTEM?

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

What is the FDA product code for INRATIO 2 PT MONITORING SYSTEM?

The FDA product code for INRATIO 2 PT MONITORING SYSTEM is GJS.

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 Hemosense, 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.

K021923INRATIO SELF-TESTK020679INRATIO

Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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.

↑