The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Piezon 250.
| Device ID | K132445 |
| 510k Number | K132445 |
| Device Name: | PIEZON 250 |
| Classification | Scaler, Ultrasonic |
| Applicant | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300 Marlborough, MA 01752 |
| Contact | Cynthia Nolte |
| Correspondent | Cynthia Nolte 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-06 |
| Decision Date | 2013-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353172442 | K132445 | 000 |
| 07613353060145 | K132445 | 000 |
| 07613353002367 | K132445 | 000 |
| 07613353002350 | K132445 | 000 |
| 07613353002343 | K132445 | 000 |
| 07613353184896 | K132445 | 000 |
| 07613353191016 | K132445 | 000 |
| 07613353208141 | K132445 | 000 |
| 07613353184902 | K132445 | 000 |
| 07613353222710 | K132445 | 000 |
| 07613353098469 | K132445 | 000 |
| 07613353100193 | K132445 | 000 |
| 07613353100209 | K132445 | 000 |
| 07613353172435 | K132445 | 000 |
| 07613353172428 | K132445 | 000 |
| 07613353168193 | K132445 | 000 |
| 07613353168186 | K132445 | 000 |
| 07613353168179 | K132445 | 000 |
| 07613353121846 | K132445 | 000 |
| 07613353121822 | K132445 | 000 |
| 07613353112318 | K132445 | 000 |
| 07613353100216 | K132445 | 000 |
| 07613353223069 | K132445 | 000 |