PACEART CPTS-86/12— 510(k) K915632

Substantially Equivalent

Paceart, Inc.

FDA 510(k) clearance K915632 for PACEART CPTS-86/12, Substantially Equivalent on 1992-04-14. Applicant: Paceart, Inc.. Device class: 2.

Clearance details

Applicant: Paceart, Inc.
Product code: Code KRE
Device class: Class 2
Regulation: 21 CFR 870.3640
Advisory panel: Cardiovascular
Date received: 1991-12-17
Decision date: 1992-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, 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.