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)

NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM

K-Number: K897004 · 1990-03-13

ApplicantAdvanced Technology Laboratories, Inc.
Decision Date1990-03-13
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1990-03-13 under 510(k) number K897004. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM?

NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-13. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K897004.

When did NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM receive FDA 510(k) clearance?

NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM received FDA 510(k) clearance on 1990-03-13, under 510(k) number K897004.

Who is the listed applicant for NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM?

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

What is the FDA product code for NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM?

The FDA product code for NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM is DXG.

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 Advanced Technology Laboratories, 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.

K021966Q LAB SOFTWAREK011224HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITYK002144MEDLINK DIAGNOSTIC OFFLINE WORKSTATIONK992470ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEMK991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMK961459LEVEL 10 HDI

View all 61 devices →

Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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.

↑