SONALIS
Transducer, Ultrasonic, Diagnostic
SMITH ASSOCIATES
The following data is part of a premarket notification filed by Smith Associates with the FDA for Sonalis.
Pre-market Notification Details
| Device ID | K100204 |
| 510k Number | K100204 |
| Device Name: | SONALIS |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SMITH ASSOCIATES 1676 VILLAGE GREEN, SUITE A Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-02-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852656007014 | K100204 | 000 |
Trademark Results [SONALIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONALIS 88008063 5679318 Live/Registered |
Best Medical International, Inc. 2018-06-20 |
 SONALIS 78747545 3227003 Dead/Cancelled |
3G Ultrasound, Inc. 2005-11-04 |
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