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510(k) K911749

L-LINEX-RAY FLUORESCENCE by Montifore Medical Center — Product Code JAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1991
Date Received
April 18, 1991
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

Other clearances for product code JAO

  • K900574 — ABIOMED BODY LEAD ANALYZER MODEL 200/20 (March 15, 1990)