NASOMETER II

GUDID 04961333236558

NASOMETER II (SOFTWARE)

PENTAX OF AMERICA, INC.

Electroglottograph
Primary Device ID04961333236558
NIH Device Record Key071b068b-7038-4e08-8773-afaae28f11fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameNASOMETER II
Version Model Number6450
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333236558 [Primary]

FDA Product Code

KLXElectroglottograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-14

On-Brand Devices [NASOMETER II]

04961333245413v4.0 NASOMETER WIN10 UPGRADE
04961333244638COMPUTERIZED SPEECH LAB (JAPAN)
04961333236558NASOMETER II (SOFTWARE)
04961333229895Nasometer

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