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510(k) K863508

Device
FRANTZ MEDICAL ELECTRODE
Applicant
FRANTZ MEDICAL DEVELOPMENT, LTD.
510(k) number
K863508
Product code
DXR  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-06
Date received
1986-09-09
Regulation
870.2320
Classification name
Ballistocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARK G FRANTZ
Address
595 Madison Ave. New York NY US 10022 10022

Source Documents#

510(k) summary PDF not indicated by FDA

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
K081603DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300Heartforce Medical, Inc.2009-07-24
K870442QUANTASCOPEVital Science Corp.1987-08-11

Legacy Summary#

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FDA Review#

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