FDA.reportPublic FDA data

510(k) K073147

Device
SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
Applicant
Transoma Medical
510(k) number
K073147
Product code
MXC
Decision
Substantially Equivalent (SESE)
Decision date
2007-12-03
Date received
2007-11-08
Regulation
870.2800
Classification name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LISA STONE
Address
4358 W. Round Lake Rd. Arden Hills MN US 55112 55112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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