GENESIS ECP— 510(k) K081359

Substantially Equivalent

Scottcare Corporation

FDA 510(k) clearance K081359 for GENESIS ECP, Substantially Equivalent on 2008-05-29. Applicant: Scottcare Corporation. Device class: 2.

Clearance details

Applicant: Scottcare Corporation
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2008-05-15
Decision date: 2008-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Cleveland, OH, 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.