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FDA 510(k)

EVENTMASTER 3 HOLTER EVENT SCANNER

K-Number: K821173 · 1982-05-18

ApplicantInstruments For Cardiac Research
Decision Date1982-05-18
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EVENTMASTER 3 HOLTER EVENT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Instruments For Cardiac Research. It received FDA 510(k) clearance on 1982-05-18 under 510(k) number K821173. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVENTMASTER 3 HOLTER EVENT SCANNER?

EVENTMASTER 3 HOLTER EVENT SCANNER is a medical device that received FDA 510(k) clearance on 1982-05-18. The listed applicant is Instruments For Cardiac Research. The 510(k) number is K821173.

When did EVENTMASTER 3 HOLTER EVENT SCANNER receive FDA 510(k) clearance?

EVENTMASTER 3 HOLTER EVENT SCANNER received FDA 510(k) clearance on 1982-05-18, under 510(k) number K821173.

Who is the listed applicant for EVENTMASTER 3 HOLTER EVENT SCANNER?

The FDA 510(k) record lists Instruments For Cardiac Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVENTMASTER 3 HOLTER EVENT SCANNER?

The FDA product code for EVENTMASTER 3 HOLTER EVENT SCANNER is DSF.

Related Clinical Trials

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Other records listing Instruments For Cardiac Research 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.

K834397HOLTER CARDIOGRAPHY SYS 6201K820856EVENTMASTER 2K820011CARDIOSTRESSK812920EVENT MASTERK801903SERIES 4000 STRESS & EXERCISE SYSTEMK771374SCANNER TREND SYSTEM

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Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, 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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