Catalog Number

-

Brand Name

ImagineMIC

Version/Model Number

IM1110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2021

Issuing Agency

In HIBCC

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

Yes

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

K172011,K172011,K172011

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

914bd733-5e6b-4058-87ff-0175fde7cd24

Public Version Date

April 13, 2022

Public Version Number

3

DI Record Publish Date

May 06, 2019

Package DI Number

B353IM11103

Quantity per Package

8

Contains DI Package

B353IM11102

Package Discontinue Date

April 30, 2021

Package Status

Not in Commercial Distribution

Package Type

Large Box