The following data is part of a premarket notification filed by Electro Medical Systems Sa with the FDA for Ems Piezon Master 600.
| Device ID | K022328 |
| 510k Number | K022328 |
| Device Name: | EMS PIEZON MASTER 600 |
| Classification | Scaler, Ultrasonic |
| Applicant | ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-18 |
| Decision Date | 2002-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353001780 | K022328 | 000 |
| 07613353175252 | K022328 | 000 |
| 07613353170448 | K022328 | 000 |
| 07613353048501 | K022328 | 000 |
| 07613353048563 | K022328 | 000 |