Sonon 300L
GUDID 00860000879842
System, Imaging, Pulsed Echo, Ultrasonic
Healcerion Co., Ltd.
Extracorporeal ultrasound imaging transducer, mounted| Primary Device ID | 00860000879842 |
| NIH Device Record Key | dac7093a-19ba-4052-a792-ef602c1bd871 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonon |
| Version Model Number | 300L |
| Catalog Number | 300L |
| Company DUNS | 688732988 |
| Company Name | Healcerion Co., Ltd. |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000879842 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170085
FDA Product Code
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2019-01-21 |
On-Brand Devices [Sonon]
| 00860000879842 | System, Imaging, Pulsed Echo, Ultrasonic |
| 00860000879835 | System, Imaging, Pulsed Doppler, Ultrasonic |
| 00860000879811 | System, Imaging, Pulse Echo, Ultrasonics |
| 00860000879804 | Transducer, Ultrasonic, Diagnostic |
Trademark Results [Sonon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONON 86614294 not registered Dead/Abandoned |
HEALCERION CO., LTD. 2015-04-29 |
 SONON 86614227 not registered Dead/Abandoned |
HEALCERION CO., LTD. 2015-04-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.