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510(k) K021054

CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER by Codonics, Inc. — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2002
Date Received
April 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type

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  • K030690 — CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS (April 30, 2003)
  • K003481 — CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 (January 19, 2001)
  • K962364 — CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD) (November 8, 1996)

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