Catalog Number

-

Brand Name

DBSWIN 5.11.0

Version/Model Number

E7200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 04, 2022

Issuing Agency

In HIBCC

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

K161444

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

61dad85b-eb22-4206-a38a-becd0d71d9bb

Public Version Date

March 07, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-