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FDA 510(k)

SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM

K-Number: K920294 · 1992-07-07

ApplicantStuart Medical, Inc.
Decision Date1992-07-07
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stuart Medical, Inc.. It received FDA 510(k) clearance on 1992-07-07 under 510(k) number K920294. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM?

SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-07-07. The listed applicant is Stuart Medical, Inc.. The 510(k) number is K920294.

When did SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM receive FDA 510(k) clearance?

SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM received FDA 510(k) clearance on 1992-07-07, under 510(k) number K920294.

Who is the listed applicant for SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM?

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

What is the FDA product code for SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM?

The FDA product code for SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM 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 Stuart Medical, 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.

K850027MEDITECH EUROSCANNER M250

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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