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FDA 510(k)

EPICARDIA, PC

K-Number: K843513 · 1984-10-22

ApplicantMedicomp, Inc.
Decision Date1984-10-22
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPICARDIA, PC is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1984-10-22 under 510(k) number K843513. 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 EPICARDIA, PC?

EPICARDIA, PC is a medical device that received FDA 510(k) clearance on 1984-10-22. The listed applicant is Medicomp, Inc.. The 510(k) number is K843513.

When did EPICARDIA, PC receive FDA 510(k) clearance?

EPICARDIA, PC received FDA 510(k) clearance on 1984-10-22, under 510(k) number K843513.

Who is the listed applicant for EPICARDIA, PC?

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

What is the FDA product code for EPICARDIA, PC?

The FDA product code for EPICARDIA, PC is DSI.

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Other records listing Medicomp, Inc. 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.

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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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