The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Air-flow Handy 3.0 Plus.
| Device ID | K151912 |
| 510k Number | K151912 |
| Device Name: | AIR-FLOW Handy 3.0 PLUS |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Rte De Champ-Colin 2 Nyon, CH Ch-1260 |
| Contact | Suzanne Fassio-hardy |
| Correspondent | Suzanne Fassio-hardy E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Rte De Champ-Colin 2 Nyon, CH Ch-1260 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-13 |
| Decision Date | 2016-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353168537 | K151912 | 000 |
| 07613353047177 | K151912 | 000 |
| 07613353047122 | K151912 | 000 |
| 07613353047153 | K151912 | 000 |
| 07613353221584 | K151912 | 000 |