MRIaudio Over-Ear Headphones - MRI-safe ear defenders provide patients with 29dB - MRIAUDIO, INC.

Duns Number:026681280

Device Description: MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients MRI-safe ear defenders provide patients with 29dB of hearing protection and allow patients to listen to audio entertainment. Do NOT require earplugs to achieve 29dB NRR. Standard two prong pneumatic headphone connection.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

330

Brand Name

MRIaudio Over-Ear Headphones

Version/Model Number

330

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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

K180100

Product Code Details

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Device Record Status

Public Device Record Key

e5cb6348-e372-40be-979c-bb14aed13148

Public Version Date

November 14, 2019

Public Version Number

2

DI Record Publish Date

October 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MRIAUDIO, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14