510(k) K781500

Device
Model 845t Imaging/ergometer Table
Applicant
QUINTON, INC.
510(k) number
K781500
Product code
JYZ
Decision
Substantially Equivalent (SESE)
Decision date
1978-09-14
Date received
1978-08-30
Regulation
874.4420
Classification name
Rod, Measuring Ear
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
1
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