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FDA 510(k)

DATAMEDIX PECGASYS SYSTEM

K-Number: K810027 · 1981-03-26

ApplicantDatamedix
Decision Date1981-03-26
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATAMEDIX PECGASYS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Datamedix. It received FDA 510(k) clearance on 1981-03-26 under 510(k) number K810027. 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 DATAMEDIX PECGASYS SYSTEM?

DATAMEDIX PECGASYS SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-26. The listed applicant is Datamedix. The 510(k) number is K810027.

When did DATAMEDIX PECGASYS SYSTEM receive FDA 510(k) clearance?

DATAMEDIX PECGASYS SYSTEM received FDA 510(k) clearance on 1981-03-26, under 510(k) number K810027.

Who is the listed applicant for DATAMEDIX PECGASYS SYSTEM?

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

What is the FDA product code for DATAMEDIX PECGASYS SYSTEM?

The FDA product code for DATAMEDIX PECGASYS SYSTEM is DSI.

Related Clinical Trials

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 Datamedix 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.

K831092PECGASYS REMOTE TRANSMISSION UNIT

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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