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FDA 510(k)

EPICARDIA PC/FC

K-Number: K883103 · 1988-09-22

ApplicantMedicomp, Inc.
Decision Date1988-09-22
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPICARDIA PC/FC is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1988-09-22 under 510(k) number K883103. 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/FC?

EPICARDIA PC/FC is a medical device that received FDA 510(k) clearance on 1988-09-22. The listed applicant is Medicomp, Inc.. The 510(k) number is K883103.

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

EPICARDIA PC/FC received FDA 510(k) clearance on 1988-09-22, under 510(k) number K883103.

Who is the listed applicant for EPICARDIA PC/FC?

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/FC?

The FDA product code for EPICARDIA PC/FC 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.

K173170Epicardia AnywhereK161916TelePatch Cardiac MonitorK091696SAVI WIRELESS, MODEL PM500K090834EPICARDIA 5000K043454CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410K981119CARDIOPAL MODEL NUMBER PM20

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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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