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510(k) K942019

MODEL FP-100 by International Medical Designs, Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1995
Date Received
April 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by International Medical Designs, Inc.

  • K934574 — MODEL MPFT-01, GENESIS (March 4, 1994)

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