The following data is part of a premarket notification filed by Ems Electro Medical Systems Sa with the FDA for Ems Air-flow Master Piezon.
| Device ID | K110173 |
| 510k Number | K110173 |
| Device Name: | EMS AIR-FLOW MASTER PIEZON |
| Classification | Scaler, Ultrasonic |
| Applicant | EMS ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J M. Nolte, Ph.d, Rac |
| Correspondent | Cynthia J M. Nolte, Ph.d, Rac EMS ELECTRO MEDICAL SYSTEMS SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | ELC |
| Subsequent Product Code | EFB |
| Subsequent Product Code | EJR |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-20 |
| Decision Date | 2011-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353172381 | K110173 | 000 |
| 07613353032012 | K110173 | 000 |
| 07613353002916 | K110173 | 000 |
| 07613353002909 | K110173 | 000 |
| 07613353002893 | K110173 | 000 |
| 07613353002541 | K110173 | 000 |
| 07613353002534 | K110173 | 000 |
| 07613353002480 | K110173 | 000 |
| 07613353002473 | K110173 | 000 |
| 07613353002404 | K110173 | 000 |
| 07613353002398 | K110173 | 000 |
| 07613353065393 | K110173 | 000 |
| 07613353064884 | K110173 | 000 |
| 07613353198671 | K110173 | 000 |
| 07613353188207 | K110173 | 000 |
| 07613353188139 | K110173 | 000 |
| 07613353050900 | K110173 | 000 |
| 07613353064853 | K110173 | 000 |
| 07613353064877 | K110173 | 000 |
| 07613353172374 | K110173 | 000 |
| 07613353172367 | K110173 | 000 |
| 07613353167875 | K110173 | 000 |
| 07613353167868 | K110173 | 000 |
| 07613353167851 | K110173 | 000 |
| 07613353166649 | K110173 | 000 |
| 07613353166069 | K110173 | 000 |
| 07613353096724 | K110173 | 000 |
| 07613353096687 | K110173 | 000 |
| 07613353096670 | K110173 | 000 |
| 07613353065447 | K110173 | 000 |
| 07613353065430 | K110173 | 000 |
| 07613353065355 | K110173 | 000 |
| 07613353065331 | K110173 | 000 |
| 07613353064976 | K110173 | 000 |
| 07613353207946 | K110173 | 000 |