BAIM CORONARY SINUS FLOW CALCULATOR— 510(k) K842831

Name: FDA 510(k) clearance K842831
Creator: U.S. Food and Drug Administration
Published: 1984-08-27

Substantially Equivalent

Electro-Catheter Corp.

FDA 510(k) clearance K842831 for BAIM CORONARY SINUS FLOW CALCULATOR, Substantially Equivalent on 1984-08-27. Applicant: Electro-Catheter Corp.. Device class: 2.

Clearance details

Applicant: Electro-Catheter Corp.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1984-07-20
Decision date: 1984-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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