Opti-Amp Power Transmitter - Multi Channel - INTELLIGENT HEARING SYSTEMS CORP.

Duns Number:154870455

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


More Product Details

Catalog Number

-

Brand Name

Opti-Amp Power Transmitter - Multi Channel

Version/Model Number

M013020P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

K052060

Product Code Details

Product Code

GWL

Product Code Name

Amplifier, Physiological Signal

Device Record Status

Public Device Record Key

6a227a53-2cfc-449e-bad5-5b4554121a24

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTELLIGENT HEARING SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 86