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FDA 510(k)

CARDIOVIEW32 REVIEW MODULE

K-Number: K083749 · 2009-03-10

ApplicantQrs Diagnostic, LLC
Decision Date2009-03-10
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIOVIEW32 REVIEW MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Qrs Diagnostic, LLC. It received FDA 510(k) clearance on 2009-03-10 under 510(k) number K083749. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVIEW32 REVIEW MODULE?

CARDIOVIEW32 REVIEW MODULE is a medical device that received FDA 510(k) clearance on 2009-03-10. The listed applicant is Qrs Diagnostic, LLC. The 510(k) number is K083749.

When did CARDIOVIEW32 REVIEW MODULE receive FDA 510(k) clearance?

CARDIOVIEW32 REVIEW MODULE received FDA 510(k) clearance on 2009-03-10, under 510(k) number K083749.

Who is the listed applicant for CARDIOVIEW32 REVIEW MODULE?

The FDA 510(k) record lists Qrs Diagnostic, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOVIEW32 REVIEW MODULE?

The FDA product code for CARDIOVIEW32 REVIEW MODULE is LOS.

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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 Qrs Diagnostic, LLC 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.

K073630MODIFICATION TO: BPCARD, MODEL Z-7000-0700K031964BPCARDK030535EKGCARD SYSTEMK001278SENSAIRE DIAGNOSTIC SPIROMETERK001995SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETERK973138SPIROCARD

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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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K073376PHILIPS 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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