The following data is part of a premarket notification filed by Sion Technology, Inc. with the FDA for Ultracalm.
| Device ID | K910625 |
| 510k Number | K910625 |
| Device Name: | ULTRACALM |
| Classification | Device, Electrical Dental Anesthesia |
| Applicant | SION TECHNOLOGY, INC. 1390 SOUTH POTOMAC ST. - 110 Aurora, CO 80012 |
| Contact | Michael W O'neill |
| Correspondent | Michael W O'neill SION TECHNOLOGY, INC. 1390 SOUTH POTOMAC ST. - 110 Aurora, CO 80012 |
| Product Code | LWM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1992-05-15 |