AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE— 510(k) K021340

Name: FDA 510(k) clearance K021340
Creator: U.S. Food and Drug Administration
Published: 2003-01-30

Substantially Equivalent

External Counterpulsation Lab

FDA 510(k) clearance K021340 for AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE, Substantially Equivalent on 2003-01-30. 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: 2002-04-26
Decision date: 2003-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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