ABIOMED BODY LEAD ANALYZER MODEL 200/20— 510(k) K900574

Name: FDA 510(k) clearance K900574
Creator: U.S. Food and Drug Administration
Published: 1990-03-15

Substantially Equivalent

Abiomed, Inc.

FDA 510(k) clearance K900574 for ABIOMED BODY LEAD ANALYZER MODEL 200/20, Substantially Equivalent on 1990-03-15. Applicant: Abiomed, Inc.. Device class: 2.

Clearance details

Applicant: Abiomed, Inc.
Product code: Code JAO
Device class: Class 2
Regulation: 21 CFR 892.1220
Advisory panel: Radiology
Date received: 1990-02-07
Decision date: 1990-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.