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)

ISCALERT SENSOR SYSTEM

K-Number: K071165 · 2007-11-07

ApplicantAlertis Medical AS
Decision Date2007-11-07
Product CodeCCC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ISCALERT SENSOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alertis Medical AS. It received FDA 510(k) clearance on 2007-11-07 under 510(k) number K071165. The device is classified under product code CCC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISCALERT SENSOR SYSTEM?

ISCALERT SENSOR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-07. The listed applicant is Alertis Medical AS. The 510(k) number is K071165.

When did ISCALERT SENSOR SYSTEM receive FDA 510(k) clearance?

ISCALERT SENSOR SYSTEM received FDA 510(k) clearance on 2007-11-07, under 510(k) number K071165.

Who is the listed applicant for ISCALERT SENSOR SYSTEM?

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

What is the FDA product code for ISCALERT SENSOR SYSTEM?

The FDA product code for ISCALERT SENSOR SYSTEM is CCC.

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: CCC)

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.

K983198TRENDCARE CALIBRATOR MODEL SCU 7007Diametrics Medical, Ltd.K972314PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEMDiametrics Medical, Ltd.K953893PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEMBiomedical Sensors, Inc.K961790POINT-OF-CARE BLOOD GAS MONITOR SYSTEMOptical Sensors, Inc.K963935OLYMPUS CRITICAL CARE MONITORING SYSTEMOptical Sensors, Inc.K951094POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEMOptical Sensors, Inc.

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.

↑