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FDA 510(k)

CARDIOTOUCH-3000

K-Number: K023034 · 2002-11-14

ApplicantBionet Company, Ltd.
Decision Date2002-11-14
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIOTOUCH-3000 is the device name listed in this FDA 510(k) record. The listed applicant is Bionet Company, Ltd.. It received FDA 510(k) clearance on 2002-11-14 under 510(k) number K023034. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTOUCH-3000?

CARDIOTOUCH-3000 is a medical device that received FDA 510(k) clearance on 2002-11-14. The listed applicant is Bionet Company, Ltd.. The 510(k) number is K023034.

When did CARDIOTOUCH-3000 receive FDA 510(k) clearance?

CARDIOTOUCH-3000 received FDA 510(k) clearance on 2002-11-14, under 510(k) number K023034.

Who is the listed applicant for CARDIOTOUCH-3000?

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

What is the FDA product code for CARDIOTOUCH-3000?

The FDA product code for CARDIOTOUCH-3000 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.

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Other records listing Bionet Company, Ltd. 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.

K023082BABYCAREK011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

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 SystemsK011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., Inc.K984465OXYCONALPHA WITH OPTION ECGErich Jaeger B.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.

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