Catalog Number

-

Brand Name

Echolight S.p.a.

Version/Model Number

EchoStation

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K202514,K202514

Product Code

MUA

Product Code Name

Bone Sonometer

Public Device Record Key

302f4512-e443-4ef3-9ea2-6911ebc8f278

Public Version Date

March 12, 2021

Public Version Number

1

DI Record Publish Date

March 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-