FDA.reportPublic FDA data

510(k) K222712

Device
Fogg System Patient Monitoring Cables
Applicant
Fogg System Company, Inc.
510(k) number
K222712
Product code
DSA
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-22
Date received
2022-09-08
Regulation
870.2900
Classification name
Cable, Transducer And Electrode, Patient, (Including Connector)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ken Neef
Address
15592 E. Batavia Dr. Aurora CO US 80011 80011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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