The following data is part of a premarket notification filed by California Technics, Inc. with the FDA for Sonus V.
| Device ID | K811396 |
| 510k Number | K811396 |
| Device Name: | SONUS V |
| Classification | Scaler, Ultrasonic |
| Applicant | CALIFORNIA TECHNICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-18 |
| Decision Date | 1981-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00636266958337 | K811396 | 000 |
| 00862872000317 | K811396 | 000 |
| 00862872000324 | K811396 | 000 |
| 00862872000331 | K811396 | 000 |
| 00862872000348 | K811396 | 000 |
| 00862872000355 | K811396 | 000 |
| 00862872000362 | K811396 | 000 |
| 00862872000379 | K811396 | 000 |
| 00636266957262 | K811396 | 000 |
| 00862872000300 | K811396 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SONUS V 73715714 1537319 Dead/Cancelled |
ENGLER ENGINEERING CORPORATION 1988-03-09 |