FDA.reportPublic FDA data

510(k) K063339

Device
MEDICK MHM200 PERSONAL HEART MONITOR
Applicant
Medick Healthcare , Ltd.
510(k) number
K063339
Product code
MLO
Decision
Substantially Equivalent (SESE)
Decision date
2007-06-29
Date received
2006-11-06
Regulation
870.2800
Classification name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JAMES W SANDBERG
Address
8303 NE Juanita Dr. Kirkland WA US 98034 98034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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