PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM— 510(k) K982090

Name: FDA 510(k) clearance K982090
Creator: U.S. Food and Drug Administration
Published: 1999-01-26

Substantially Equivalent

Paceart, Inc.

FDA 510(k) clearance K982090 for PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM, Substantially Equivalent on 1999-01-26. Applicant: Paceart, Inc.. Device class: 2.

Clearance details

Applicant: Paceart, Inc.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 1998-06-15
Decision date: 1999-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

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