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510(k) K042361

DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D by Sedecal USA, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2004
Date Received
August 31, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Sedecal USA, Inc.

  • K012546 — OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM (November 2, 2001)
  • K012663 — EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) (August 31, 2001)

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