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510(k) K101109

Device
VIVATRAK
Applicant
WIRELESS MEDCARE, LLC
510(k) number
K101109
Product code
KMI  
Decision
Substantially Equivalent (SESE)
Decision date
2010-07-15
Date received
2010-04-20
Regulation
880.2400
Classification name
Monitor, Bed Patient
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAUL SUMNER
Address
1733 Canton Ln. Marietta GA US 30062 30062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KMI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141877LEAF PATIENT MONITORING SYSTEMLeaf Healthcare, Inc.2014-11-10
K131585INTEL-GE CARE INNOVATIONS QUIETCAREIntel-Ge Care Innovations, LLC2013-10-08
K130752DYNASENSE SYSTEMCentauri Medical, Inc.2013-08-15
K090138MOBILECARE MONITOR, MODEL 2100Aframe Digital, Inc.2009-04-24
K942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITORUltimate Development Corp.1994-12-23
K943481INFORMER PLUSMicro-Tech Medical, Inc.1994-11-02
K933552PM-PAGERHill Engineering1994-09-22
K934344HOME AMB-ALERTMedway1994-04-29
K940405TELETOMBerchtold Holding GmbH1994-04-14
K924433SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1Senior Technologies, Inc.1993-06-24
K925529WANDER CARECare Electronics, Inc.1993-06-16
K920206POSEY SITTERJ. T. Posey Co.1992-05-14
K914859BARTRONIX IN-BED ACTIVITY MONITORBartronix1992-04-13
K911079AMB-ALERTMedway1991-09-13
K905586RSVP RF-2000Tactilitics, Inc.1991-04-01

Legacy Summary#

summary

FDA Review#

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