CinemaVision - Audio/Video MRI Patient comfort device - RESONANCE TECHNOLOGY, INC.

Duns Number:622142123

Device Description: Audio/Video MRI Patient comfort device

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More Product Details

Catalog Number

-

Brand Name

CinemaVision

Version/Model Number

RTC550

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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"

Yes

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

K994351

Product Code Details

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Device Record Status

Public Device Record Key

c3719781-2fa3-483e-ad52-ccee4e19cde9

Public Version Date

March 06, 2020

Public Version Number

1

DI Record Publish Date

February 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESONANCE TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1