CHART PROJECTOR

Basic Information

• Brand Name: CHART PROJECTOR
• Primary DI: 04987669100059
• Version / Model: CP-770
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f41bb339-3ee6-4f6d-aeb1-2f4891e7ab64

Device Description

The NIDEK Chart Projector CP-770 is a test chart presenting device which can achieve refraction distance from 2.9 m to 6.1 m. The device is controlled by a wireless remote control or a control box on the refractor (RT). The CP-770 features the following: • Equipped with 33 types of charts (27 types for Type UK) including various kinds of binocular charts • Program function that allows chart presentation with the touch of a button • Versatile masking function that can even offer the display of even a single character • Chart brightness adjustability to the installation conditions • Switchable function between display and non-display of visual acuity of the chart • A long-life LED for the illumination light source

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOX	Chart, Visual Acuity	Ophthalmic	886.1150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35922	Visual acuity projector	A mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100059	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]