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FDA 510(k)

CARDIOVISE ECG INTERPRETATIVE SOFTWARE

K-Number: K001349 · 2000-07-27

ApplicantInovise Medical, Inc.
Decision Date2000-07-27
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVISE ECG INTERPRETATIVE SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Inovise Medical, Inc.. It received FDA 510(k) clearance on 2000-07-27 under 510(k) number K001349. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVISE ECG INTERPRETATIVE SOFTWARE?

CARDIOVISE ECG INTERPRETATIVE SOFTWARE is a medical device that received FDA 510(k) clearance on 2000-07-27. The listed applicant is Inovise Medical, Inc.. The 510(k) number is K001349.

When did CARDIOVISE ECG INTERPRETATIVE SOFTWARE receive FDA 510(k) clearance?

CARDIOVISE ECG INTERPRETATIVE SOFTWARE received FDA 510(k) clearance on 2000-07-27, under 510(k) number K001349.

Who is the listed applicant for CARDIOVISE ECG INTERPRETATIVE SOFTWARE?

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

What is the FDA product code for CARDIOVISE ECG INTERPRETATIVE SOFTWARE?

The FDA product code for CARDIOVISE ECG INTERPRETATIVE SOFTWARE is MWJ.

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Other records listing Inovise 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.

K151433AUDICOR CA300/CC100 Analyzer with SDBK130660AUDICOR CPAM WITH SDB (SINGLE SENSOR)K120462AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)K103516AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0K080602AUDICOR SENSOR, MODELS: 2.0, 3.0

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Related Devices (Code: MWJ)

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.

K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, 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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