The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Ems Piezon 707 Bik And Piezon 707 Bik Led.
| Device ID | K140990 |
| 510k Number | K140990 |
| Device Name: | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED |
| Classification | Scaler, Ultrasonic |
| Applicant | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300 Marlborough, MA 01752 |
| Contact | Tina Wu |
| Correspondent | Tina Wu E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300 Marlborough, MA 01752 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-17 |
| Decision Date | 2015-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353111564 | K140990 | 000 |
| 07613353089375 | K140990 | 000 |
| 07613353089382 | K140990 | 000 |