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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, mobile
510(k) Number K020436
Device Name PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0
Applicant
SEDECAL S.A.
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
SEDECAL S.A.
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number892.1720
Classification Product Code
IZL  
Date Received02/08/2002
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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