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FDA 510(k)

MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11

K-Number: K900607 · 1990-10-16

ApplicantCardiodata Corp.
Decision Date1990-10-16
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiodata Corp.. It received FDA 510(k) clearance on 1990-10-16 under 510(k) number K900607. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11?

MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 is a medical device that received FDA 510(k) clearance on 1990-10-16. The listed applicant is Cardiodata Corp.. The 510(k) number is K900607.

When did MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 receive FDA 510(k) clearance?

MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 received FDA 510(k) clearance on 1990-10-16, under 510(k) number K900607.

Who is the listed applicant for MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11?

The FDA 510(k) record lists Cardiodata Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11?

The FDA product code for MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 is DSI.

Related Clinical Trials

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Other records listing Cardiodata Corp. 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.

K881488HOLTER SCANNERK873337MODEL SSR1 HOLTER MONITORK860167PRODIGY AND PRODIGY PLUS

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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