Cleared Traditional

ABIOMED BODY LEAD ANALYZER MODEL 200/20

K900574 · Abiomed, Inc. · Radiology

Mar 1990

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K900574 is an FDA 510(k) clearance for the ABIOMED BODY LEAD ANALYZER MODEL 200/20, a Scanner, Fluorescent (Class II — Special Controls, product code JAO), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on March 15, 1990, 36 days after receiving the submission on February 7, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1220.

Submission Details

510(k) Number	K900574 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 1990
Decision Date	March 15, 1990
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—