FDA.reportPublic FDA data

510(k) K813123

Device
Epc Filter
Applicant
Codman & Shurtleff, Inc.
510(k) number
K813123
Product code
DRR
Decision
Substantially Equivalent (SESE)
Decision date
1981-11-27
Date received
1981-11-04
Regulation
870.2050
Classification name
Amplifier And Signal Conditioner, Biopotential
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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