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FDA 510(k)

EPICARDIA LE/FD

K-Number: K881770 · 1988-05-31

ApplicantMedicomp, Inc.
Decision Date1988-05-31
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPICARDIA LE/FD is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1988-05-31 under 510(k) number K881770. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPICARDIA LE/FD?

EPICARDIA LE/FD is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Medicomp, Inc.. The 510(k) number is K881770.

When did EPICARDIA LE/FD receive FDA 510(k) clearance?

EPICARDIA LE/FD received FDA 510(k) clearance on 1988-05-31, under 510(k) number K881770.

Who is the listed applicant for EPICARDIA LE/FD?

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 LE/FD?

The FDA product code for EPICARDIA LE/FD is DQK.

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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: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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