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FDA 510(k)

EPICARDIA 5000

K-Number: K090834 · 2009-05-15

ApplicantMedicomp, Inc.
Decision Date2009-05-15
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPICARDIA 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 2009-05-15 under 510(k) number K090834. 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 5000?

EPICARDIA 5000 is a medical device that received FDA 510(k) clearance on 2009-05-15. The listed applicant is Medicomp, Inc.. The 510(k) number is K090834.

When did EPICARDIA 5000 receive FDA 510(k) clearance?

EPICARDIA 5000 received FDA 510(k) clearance on 2009-05-15, under 510(k) number K090834.

Who is the listed applicant for EPICARDIA 5000?

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 5000?

The FDA product code for EPICARDIA 5000 is DSI.

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Other records listing Medicomp, Inc. as applicant

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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.

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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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