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FDA 510(k)

EKG-PLUS II SOFTWARE

K-Number: K090895 · 2009-08-26

ApplicantBionet Co., Ltd.
Decision Date2009-08-26
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

EKG-PLUS II SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Bionet Co., Ltd.. It received FDA 510(k) clearance on 2009-08-26 under 510(k) number K090895. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKG-PLUS II SOFTWARE?

EKG-PLUS II SOFTWARE is a medical device that received FDA 510(k) clearance on 2009-08-26. The listed applicant is Bionet Co., Ltd.. The 510(k) number is K090895.

When did EKG-PLUS II SOFTWARE receive FDA 510(k) clearance?

EKG-PLUS II SOFTWARE received FDA 510(k) clearance on 2009-08-26, under 510(k) number K090895.

Who is the listed applicant for EKG-PLUS II SOFTWARE?

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

What is the FDA product code for EKG-PLUS II SOFTWARE?

The FDA product code for EKG-PLUS II SOFTWARE is LOS.

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Other records listing Bionet Co., 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.

K231160Cardio Q50, Cardio Q70K231150Cardio P1K220535Cardio10K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)K130322SPM-300K113306CARDIO 7

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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.

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.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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