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510(k) K081603

Device
DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
Applicant
HEARTFORCE MEDICAL, INC.
510(k) number
K081603
Product code
DXR  
Decision
Substantially Equivalent (SESE)
Decision date
2009-07-24
Date received
2008-06-06
Regulation
870.2320
Classification name
Ballistocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ARTHUR WARD
Address
962 Allegro Ln. Appollo Beach FL US 33572 33572

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243566CardioTag™Cardiosense, Inc.2025-07-22
K160656CorSensCorsens Medical , Ltd.2016-11-21
K870442QUANTASCOPEVital Science Corp.1987-08-11
K863508FRANTZ MEDICAL ELECTRODEFrantz Medical Development, Ltd.1987-02-06

Legacy Summary#

summary

FDA Review#

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