NA - MINI FLAT JUNCTION BOX for EEG1200 - NIHON KOHDEN AMERICA, INC.

Duns Number:021063219

Device Description: MINI FLAT JUNCTION BOX for EEG1200

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More Product Details

Catalog Number

JE-217AK

Brand Name

NA

Version/Model Number

JE-217AK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

Yes

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

OLV

Product Code Name

Standard polysomnograph with electroencephalograph

Device Record Status

Public Device Record Key

6ad11650-e3ee-4c9a-9f07-1d29a6b5a24a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NIHON KOHDEN AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 393