PREDICTOR II SIGNAL AVERAGING ECG— 510(k) K883855

Name: FDA 510(k) clearance K883855
Creator: U.S. Food and Drug Administration
Published: 1988-11-03

Substantially Equivalent

Corazonix Corp.

FDA 510(k) clearance K883855 for PREDICTOR II SIGNAL AVERAGING ECG, Substantially Equivalent on 1988-11-03. Applicant: Corazonix Corp.. Device class: 2.

Clearance details

Applicant: Corazonix Corp.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1988-09-13
Decision date: 1988-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

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