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510(k) K990123

Device
PVR-100/VASOGRAM
Applicant
VASOCOR, INC.
510(k) number
K990123
Product code
JOM  
Decision
Substantially Equivalent (SESE)
Decision date
1999-04-12
Date received
1999-01-13
Regulation
870.2780
Classification name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFF RAINES
Address
7705 NW 48th St., Suite 120 Miami FL US 33166 33166

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JOM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix2022-10-20
K213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.2022-04-21
K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.2021-02-26
K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.2020-12-11
K191266VitalScan ANSMedeia, Inc.2020-01-15
K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.2018-01-11
K173696TBL-ABI SystemLd Technology, LLC2017-12-19
K143152TM-ABI systemLd Technology, LLC2015-07-22
K143094QuantaFloSemler Scientific, Inc.2015-03-05
K123921BODYTRONIC 200Bauerfeind AG2013-04-26
K121108DOPPLEX ABILITYHuntleigh Healthcare2013-01-03
K122281PADNET 2.0Biomedix, Inc.2012-08-29
K110374MAX PULSE SYSTEMMedicore Co., Ltd.2011-06-13
K101983CRITICAL CARE ASSESSMENTCritical Patient Care, Inc.2010-09-21
K093192FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICEAdvanced Vascular Dynamics2010-02-12

Legacy Summary#

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FDA Review#

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