Zoom Slit Lamp - The RS-1000 zoom slit lamps are designed for - RIGHT MFG. CO., LTD.

Duns Number:713383495

Device Description: The RS-1000 zoom slit lamps are designed for ophthalmic observation and microphotography. The RS-1000 zoom slit lamps are designed for ophthalmic observation and microphotography. These slit lamps feature zoom stereoscopic converging microscopes that can be used for ophthalmic observation.This equipment is intended for use by medical doctors and optometrists.Each instrument consists primarily of the main unit and the illumination power supply unit.consisting of:・Program control unit (120V) ・Trigger Circuit longer cord 2.95m & Main body cord + 1m・Digital Camera Adapter・Back ground Light for Flash・Cord Guide consisting of 4 Clamps and 1 Cover ・Flash Tube-1・Table for Program Power Box ・UL Power supply Cord Hospital Grade(120V)

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More Product Details

Catalog Number

-

Brand Name

Zoom Slit Lamp

Version/Model Number

RS-1000

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

K060869

Product Code Details

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Device Record Status

Public Device Record Key

68f4d6be-c242-48ba-b262-50eab9796448

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

July 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RIGHT MFG. CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21