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FDA 510(k)

ECP HEALTH SYSTEM, MODEL 2005

K-Number: K052611 · 2006-04-26

ApplicantEcp Health, Inc.
Decision Date2006-04-26
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECP HEALTH SYSTEM, MODEL 2005 is the device name listed in this FDA 510(k) record. The listed applicant is Ecp Health, Inc.. It received FDA 510(k) clearance on 2006-04-26 under 510(k) number K052611. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECP HEALTH SYSTEM, MODEL 2005?

ECP HEALTH SYSTEM, MODEL 2005 is a medical device that received FDA 510(k) clearance on 2006-04-26. The listed applicant is Ecp Health, Inc.. The 510(k) number is K052611.

When did ECP HEALTH SYSTEM, MODEL 2005 receive FDA 510(k) clearance?

ECP HEALTH SYSTEM, MODEL 2005 received FDA 510(k) clearance on 2006-04-26, under 510(k) number K052611.

Who is the listed applicant for ECP HEALTH SYSTEM, MODEL 2005?

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

What is the FDA product code for ECP HEALTH SYSTEM, MODEL 2005?

The FDA product code for ECP HEALTH SYSTEM, MODEL 2005 is DRN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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