FDA.reportPublic FDA data

510(k) K813176

Device
Gel Electrode
Applicant
DYN-A-MED PRODUCTS
510(k) number
K813176
Product code
DRX
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-29
Date received
1981-11-12
Regulation
870.2360
Classification name
Electrode, Electrocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
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

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