n/a - SPEECH MSTR UPGRADE SP2,REV.C - PENTAX OF AMERICA, INC.

Duns Number:083211284

Device Description: SPEECH MSTR UPGRADE SP2,REV.C

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


More Product Details

Catalog Number

-

Brand Name

n/a

Version/Model Number

7193-7700

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

-

Product Code Details

Product Code

KLX

Product Code Name

Electroglottograph

Device Record Status

Public Device Record Key

b0194224-910d-4b07-a830-23fb018bb7b0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PENTAX OF AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 247
2 A medical device with a moderate to high risk that requires special controls. 425