The following data is part of a premarket notification filed by Satelec with the FDA for Team-up Tm Dental Electronic Anesthesia System.
| Device ID | K011001 |
| 510k Number | K011001 |
| Device Name: | TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM |
| Classification | Device, Electrical Dental Anesthesia |
| Applicant | SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Contact | Jean-luc Boulnois |
| Correspondent | Jean-luc Boulnois SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| 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 | 2001-03-09 |
| Decision Date | 2001-06-07 |