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)

CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)

K-Number: K902460 · 1990-08-28

ApplicantOakfield Instruments, Ltd.
Decision Date1990-08-28
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) is the device name listed in this FDA 510(k) record. The listed applicant is Oakfield Instruments, Ltd.. It received FDA 510(k) clearance on 1990-08-28 under 510(k) number K902460. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)?

CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) is a medical device that received FDA 510(k) clearance on 1990-08-28. The listed applicant is Oakfield Instruments, Ltd.. The 510(k) number is K902460.

When did CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) receive FDA 510(k) clearance?

CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) received FDA 510(k) clearance on 1990-08-28, under 510(k) number K902460.

Who is the listed applicant for CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)?

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

What is the FDA product code for CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)?

The FDA product code for CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) is IZD.

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 Oakfield Instruments, Ltd. 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.

K964804FLEXILOG LSK964589FLEXILOG 3000K961895FLEXILOG LS 13921K945069FLEXILOG 2000K920115MEDISCINTK896288FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM

View all 8 devices →

Related Devices (Code: IZD)

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.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.

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.

↑