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510(k) K121929

Device
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
Applicant
DIACOR, INC.
510(k) number
K121929
Product code
FRZ  
Decision
Substantially Equivalent (SESE)
Decision date
2013-01-17
Date received
2012-07-02
Regulation
880.6775
Classification name
Device, Patient Transfer, Powered
Medical specialty
General Hospital
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KEVIN ANDERSON
Address
2550 Decker Lake Blvd. Suite 26 West Valley City UT US 84119 84119

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FRZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K910830INVALIFTAmerican Invalift Corp.1992-06-09
K841728LCI MEDICAL INC AIR/PALLehigh Consolidated Industries1984-06-05
K834585CELLTRAK-BR&D Systems, Inc.1984-05-02
K840796TENDER LIFTING CARELancer Assoc.1984-04-20

Legacy Summary#

summary

FDA Review#

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