Chart Projector HCP-7000 - chart projector is intended to be used to check - Huvitz Co., Ltd.

Duns Number:688154202

Device Description: chart projector is intended to be used to check eye optometry

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More Product Details

Catalog Number

HCP-7000

Brand Name

Chart Projector HCP-7000

Version/Model Number

HCP-7000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HOS

Product Code Name

Projector, Ophthalmic

Device Record Status

Public Device Record Key

dd0f8a9f-e967-4fc2-a8d3-17dafe796b47

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 10, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HUVITZ CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 15