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)

M-MODE ANALYSIS SYSTEM

K-Number: K822425 · 1982-10-04

ApplicantUser Resources, Inc.
Decision Date1982-10-04
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M-MODE ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is User Resources, Inc.. It received FDA 510(k) clearance on 1982-10-04 under 510(k) number K822425. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-MODE ANALYSIS SYSTEM?

M-MODE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1982-10-04. The listed applicant is User Resources, Inc.. The 510(k) number is K822425.

When did M-MODE ANALYSIS SYSTEM receive FDA 510(k) clearance?

M-MODE ANALYSIS SYSTEM received FDA 510(k) clearance on 1982-10-04, under 510(k) number K822425.

Who is the listed applicant for M-MODE ANALYSIS SYSTEM?

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

What is the FDA product code for M-MODE ANALYSIS SYSTEM?

The FDA product code for M-MODE ANALYSIS SYSTEM is DXK.

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: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics 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.

↑