PACEART TX3 CARDIAC EVENT RECORDER— 510(k) K012407

Name: FDA 510(k) clearance K012407
Creator: U.S. Food and Drug Administration
Published: 2001-08-14

Substantially Equivalent

Paceart, Inc.

FDA 510(k) clearance K012407 for PACEART TX3 CARDIAC EVENT RECORDER, Substantially Equivalent on 2001-08-14. 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: 2001-07-30
Decision date: 2001-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

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