LeSono

GUDID 04719882150050

LELTEK INC.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID04719882150050
NIH Device Record Key9e026b80-cb0e-44fb-8db5-c23c24f4fd25
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeSono
Version Model NumberLU700C
Company DUNS656116467
Company NameLELTEK INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719882150050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


[04719882150050]

Chlorine Dioxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18

On-Brand Devices [LeSono]

04719882150050LU700C
04719882150043LU700
04719882150067LU700L

Trademark Results [LeSono]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LESONO
LESONO
79206693 5557613 Live/Registered
Cleac Oy
2016-12-15

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