Digital Chart HDC-9000 HDC-9000

GUDID 08800019600190

Digital Chart is a computerized chart presenting device that provides charts for refractive correction test and various functional tests

Huvitz Co., Ltd.

Vision testing/training chart
Primary Device ID08800019600190
NIH Device Record Key4a36a5c6-2181-41b3-8c4d-6587a7e80aba
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital Chart HDC-9000
Version Model NumberHDC-9000
Catalog NumberHDC-9000
Company DUNS688154202
Company NameHuvitz Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82314289100
Emailsvc@huvitz.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800019600190 [Primary]

FDA Product Code

HOXChart, Visual Acuity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-22
Device Publish Date2019-05-10

Devices Manufactured by Huvitz Co., Ltd.

08800019600978 - Instrument Table CIT-41002024-07-02 Instrument Table CIT-4100
08800019600985 - Instrument Table CIT-42002024-07-02 Instrument Table CIT-4200
08800019600893 - Lilivis Scan LS-1002024-06-04 Lilivis Scan LS-100 (Intraoral Scanner)
08800019600909 - Lilivis CAD L-CAD2024-06-04 Lilivis CAD L-CAD (Chairside CAD Software)
08800019600787 - Optical Biometer HBM-12023-10-26 The Optical Biometer HBM-1 is a medical device that optically measures eye components such as: *Axial length *Corneal curvature
08800019600916 - Digital Refractor HDR-7100P2023-09-01 The HUVITZ Digital Refractor HDR-7100P system is a computerized auto refractor used for subjective refraction by regarding the p
08800019600923 - Auto Ref/Keratometer HRK-8100A2023-09-01 Auto Ref/Keratometer HRK-8100A is intended to provide the information of Spherical, Cylindrical and Axis while measuring the ref
08800019600411 - Applanation Tonometer HT-50002023-06-20 Applanation Tonometer HT-5000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.