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FDA 510(k)

EPICARDIA

K-Number: K952846 · 1995-09-18

ApplicantMedicomp, Inc.
Decision Date1995-09-18
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPICARDIA is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1995-09-18 under 510(k) number K952846. 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?

EPICARDIA is a medical device that received FDA 510(k) clearance on 1995-09-18. The listed applicant is Medicomp, Inc.. The 510(k) number is K952846.

When did EPICARDIA receive FDA 510(k) clearance?

EPICARDIA received FDA 510(k) clearance on 1995-09-18, under 510(k) number K952846.

Who is the listed applicant for EPICARDIA?

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?

The FDA product code for EPICARDIA 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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