PACEMAKER FUNCTION ANALYZER— 510(k) K870909

Substantially Equivalent

Paceart, Inc.

FDA 510(k) clearance K870909 for PACEMAKER FUNCTION ANALYZER, Substantially Equivalent on 1987-04-27. 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: 1987-03-05
Decision date: 1987-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millburn, 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.