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510(k) K183485

Device
CryoVizion System
Applicant
Cryos Technologies Inc.
510(k) number
K183485
Product code
LDK  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-28
Date received
2018-12-17
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
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
John A. Stimpson
Address
385 Rue Salaberry Joliette CA J6E 4G4 J6E 4G4

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K800591CONTOUROGRAPH M-500Bio-Tek Instruments, Inc.1980-04-02

Legacy Summary#

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FDA Review#

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