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510(k) K012663

EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) by Sedecal USA, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2001
Date Received
August 13, 2001
Clearance Type
Traditional
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.

  • K042361 — DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D (September 29, 2004)
  • K012546 — OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM (November 2, 2001)

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