FDA.reportPublic FDA data

510(k) K834585

Device
Celltrak-b
Applicant
R & D SYSTEMS, INC.
510(k) number
K834585
Product code
FRZ
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-02
Date received
1983-12-29
Regulation
880.6775
Classification name
Device, Patient Transfer, Powered
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FRZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121929ZEPHYR 'X-SERIES PATIENT TRANSFER SLEDDiacor, Inc.2013-01-17
K910830INVALIFTAmerican Invalift Corp.1992-06-09
K841728LCI MEDICAL INC AIR/PALLehigh Consolidated Industries1984-06-05
K840796TENDER LIFTING CARELancer Assoc.1984-04-20