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FDA 510(k)

CT 200 ELECTROCARDIOGRAPH

K-Number: K961798 · 1998-08-05

ApplicantMacquarie Medical Systems
Decision Date1998-08-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CT 200 ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Macquarie Medical Systems. It received FDA 510(k) clearance on 1998-08-05 under 510(k) number K961798. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT 200 ELECTROCARDIOGRAPH?

CT 200 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Macquarie Medical Systems. The 510(k) number is K961798.

When did CT 200 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

CT 200 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1998-08-05, under 510(k) number K961798.

Who is the listed applicant for CT 200 ELECTROCARDIOGRAPH?

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

What is the FDA product code for CT 200 ELECTROCARDIOGRAPH?

The FDA product code for CT 200 ELECTROCARDIOGRAPH is DPS.

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 Macquarie Medical Systems 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.

K981951CT 100 ELECTROCARDIOGRAPH

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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