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FDA 510(k)

SERIES 4000 STRESS & EXERCISE SYSTEM

K-Number: K801903 · 1981-03-11

ApplicantInstruments For Cardiac Research
Decision Date1981-03-11
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SERIES 4000 STRESS & EXERCISE SYSTEM 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 1981-03-11 under 510(k) number K801903. 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 SERIES 4000 STRESS & EXERCISE SYSTEM?

SERIES 4000 STRESS & EXERCISE SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Instruments For Cardiac Research. The 510(k) number is K801903.

When did SERIES 4000 STRESS & EXERCISE SYSTEM receive FDA 510(k) clearance?

SERIES 4000 STRESS & EXERCISE SYSTEM received FDA 510(k) clearance on 1981-03-11, under 510(k) number K801903.

Who is the listed applicant for SERIES 4000 STRESS & EXERCISE SYSTEM?

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 SERIES 4000 STRESS & EXERCISE SYSTEM?

The FDA product code for SERIES 4000 STRESS & EXERCISE SYSTEM is DSI.

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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 6201K821173EVENTMASTER 3 HOLTER EVENT SCANNERK820856EVENTMASTER 2K820011CARDIOSTRESSK812920EVENT MASTERK771374SCANNER TREND SYSTEM

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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

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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