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510(k) K900574

ABIOMED BODY LEAD ANALYZER MODEL 200/20 by Abiomed, Inc. — Product Code JAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1990
Date Received
February 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scanner, Fluorescent
Device Class
Class II
Regulation Number
892.1220
Review Panel
RA
Submission Type

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Other clearances for product code JAO

  • K911749 — L-LINEX-RAY FLUORESCENCE (August 20, 1991)