ACS MODEL NCP-2— 510(k) K042413

Substantially Equivalent

Applied Cardiac Systems

FDA 510(k) clearance K042413 for ACS MODEL NCP-2, Substantially Equivalent on 2004-12-09. Applicant: Applied Cardiac Systems. Device class: 2.

Clearance details

Applicant: Applied Cardiac Systems
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2004-09-07
Decision date: 2004-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, 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.