ECP HEALTH SYSTEM, MODEL 2005— 510(k) K052611

Substantially Equivalent

Ecp Health, Inc.

FDA 510(k) clearance K052611 for ECP HEALTH SYSTEM, MODEL 2005, Substantially Equivalent on 2006-04-26. Applicant: Ecp Health, Inc.. Device class: 2.

Clearance details

Applicant: Ecp Health, Inc.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2005-09-22
Decision date: 2006-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.