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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, patient transfer, powered
510(k) Number K121929
Device Name ZEPHYR 'X-SERIES" PATIENT TRANSFER SLED
Original Applicant
DIACOR, INC.
2550 decker lake blvd.
suite 26
west valley city,  UT  84119
Original Contact kevin anderson
Regulation Number880.6775
Classification Product Code
FRZ  
Subsequent Product Codes
IYE   LHN   LNH  
Date Received07/02/2012
Decision Date 01/17/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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