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FDA 510(k)

CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

K-Number: K011328 · 2001-11-21

ApplicantBionet Company, Ltd.
Decision Date2001-11-21
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH 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 2001-11-21 under 510(k) number K011328. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH?

CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 2001-11-21. The listed applicant is Bionet Company, Ltd.. The 510(k) number is K011328.

When did CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH received FDA 510(k) clearance on 2001-11-21, under 510(k) number K011328.

Who is the listed applicant for CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH?

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 CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH?

The FDA product code for CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH is LOS.

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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.

K023082BABYCAREK023034CARDIOTOUCH-3000

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.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., Inc.K984465OXYCONALPHA WITH OPTION ECGErich Jaeger B.V.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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