Compumedics SynAmps RT - Package, Headbox - SynAmps RT 64-Channel - COMPUMEDICS LIMITED

Duns Number:753750967

Device Description: Package, Headbox - SynAmps RT 64-Channel

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More Product Details

Catalog Number

9032-0001-01

Brand Name

Compumedics SynAmps RT

Version/Model Number

SynAmps RT

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K023771

Product Code Details

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Device Record Status

Public Device Record Key

23fd175b-b76d-4a08-ae99-06d0b8d5787f

Public Version Date

April 27, 2021

Public Version Number

4

DI Record Publish Date

December 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPUMEDICS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 53