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)

ECG REVIEW STATION

K-Number: K942685 · 1997-08-12

ApplicantMortara Instrument, Inc.
Decision Date1997-08-12
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG REVIEW STATION is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 1997-08-12 under 510(k) number K942685. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG REVIEW STATION?

ECG REVIEW STATION is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K942685.

When did ECG REVIEW STATION receive FDA 510(k) clearance?

ECG REVIEW STATION received FDA 510(k) clearance on 1997-08-12, under 510(k) number K942685.

Who is the listed applicant for ECG REVIEW STATION?

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

What is the FDA product code for ECG REVIEW STATION?

The FDA product code for ECG REVIEW STATION is DXJ.

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 Mortara Instrument, 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.

K182297Surveyor S2K173765Surveyor Patient MonitorK161517Mortara Surveyor Patient MonitorK161465CardioConfirmK160685Surveyor S4 Mobile MonitorK152626H3+ Holter Recorder

View all 47 devices →

Related Devices (Code: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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.

↑