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FDA 510(k)

CARDIOVIEW 3000 SOFTWARE

K-Number: K974352 · 1998-09-08

ApplicantMicromedical, Inc.
Decision Date1998-09-08
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIOVIEW 3000 SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical, Inc.. It received FDA 510(k) clearance on 1998-09-08 under 510(k) number K974352. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVIEW 3000 SOFTWARE?

CARDIOVIEW 3000 SOFTWARE is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Micromedical, Inc.. The 510(k) number is K974352.

When did CARDIOVIEW 3000 SOFTWARE receive FDA 510(k) clearance?

CARDIOVIEW 3000 SOFTWARE received FDA 510(k) clearance on 1998-09-08, under 510(k) number K974352.

Who is the listed applicant for CARDIOVIEW 3000 SOFTWARE?

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

What is the FDA product code for CARDIOVIEW 3000 SOFTWARE?

The FDA product code for CARDIOVIEW 3000 SOFTWARE is LOS.

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 Micromedical, 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.

K974220MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEK974351BIOLOG 3000 ELECTROCARDIOGRAPHK970305PRINTER INTERFACEK955891CARDIOVIEW TRANSTELEPHONIC SOFTWARE

Related Devices (Code: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., 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.

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