LeSono
GUDID 04719882150043
LELTEK INC.
General-purpose ultrasound imaging system| Primary Device ID | 04719882150043 |
| NIH Device Record Key | 734aba36-2127-4d75-b4d6-4a0ad205c6fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LeSono |
| Version Model Number | LU700 |
| Company DUNS | 656116467 |
| Company Name | LELTEK INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719882150043 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191235
FDA Product Code
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
[04719882150043]
Chlorine Dioxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-26 |
| Device Publish Date | 2021-01-18 |
On-Brand Devices [LeSono]
| 04719882150050 | LU700C |
| 04719882150043 | LU700 |
| 04719882150067 | LU700L |
Trademark Results [LeSono]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LESONO 79206693 5557613 Live/Registered |
Cleac Oy 2016-12-15 |
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