AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE— 510(k) K012141

Name: FDA 510(k) clearance K012141
Creator: U.S. Food and Drug Administration
Published: 2001-10-25

Substantially Equivalent

External Counterpulsation Lab

FDA 510(k) clearance K012141 for AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE, Substantially Equivalent on 2001-10-25. Applicant: External Counterpulsation Lab. Device class: 2.

Clearance details

Applicant: External Counterpulsation Lab
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 2001-07-10
Decision date: 2001-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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