PACEART OPTIMA SYSTEM SOFTWARE— 510(k) K110693

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K110693 for PACEART OPTIMA SYSTEM SOFTWARE, Substantially Equivalent on 2011-06-08. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code KRE
Device class: Class 2
Regulation: 21 CFR 870.3640
Advisory panel: Cardiovascular
Date received: 2011-03-11
Decision date: 2011-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, 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.