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510(k) K800591

Device
CONTOUROGRAPH M-500
Applicant
BIO-TEK INSTRUMENTS, INC.
510(k) number
K800591
Product code
LDK  
Decision
Substantially Equivalent (SESE)
Decision date
1980-04-02
Date received
1980-03-17
Regulation
510(k) Premarket Notification
Classification name
Device, Sensing, Optical Contour
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Physical Medicine
Device class
U
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230463NSite Scoliosis Assessment AppNsite, Inc.2023-11-15
K232023Momentum SpineMomentum Health, Inc.2023-10-04
K183485CryoVizion SystemCryos Technologies, Inc.2019-08-28
K923792QUANTEC SPINAL MEASUEMENT SYSTEMQuantec Image Processing , Ltd.1994-04-20
K860225METRICOMFar Orthopedics, Inc.1986-02-11
K851133TERRAN BIOMECHANICAL ANALYSIS SYSTEMTerran Biomedical Instruments1985-06-19
K844736ISISOxford Medilog, Inc.1985-03-21

Legacy Summary#

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FDA Review#

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