Catalog Number

9016C0701

Brand Name

MagPro

Version/Model Number

MEP Monitor (incl. 0.7mm cable and electrodes)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 13, 9999

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K162873

Product Code

OBP

Product Code Name

Transcranial Magnetic Stimulator

Public Device Record Key

f36a9f66-c00d-4465-993c-48de24b5474b

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

June 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-