The following data is part of a premarket notification filed by Electro Medical Systems (ems Sa) with the FDA for Air Flow Sii.
| Device ID | K900709 |
| 510k Number | K900709 |
| Device Name: | AIR FLOW SII |
| Classification | Scaler, Ultrasonic |
| Applicant | ELECTRO MEDICAL SYSTEMS (EMS SA) RTE DE CHAMP-COLIN 2 Nyon,vaud, CH Ch-1260 |
| Contact | Maurice Piche |
| Correspondent | Maurice Piche ELECTRO MEDICAL SYSTEMS (EMS SA) RTE DE CHAMP-COLIN 2 Nyon,vaud, CH Ch-1260 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-30 |
| Decision Date | 1990-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353172312 | K900709 | 000 |
| 07613353077297 | K900709 | 000 |
| 07613353056698 | K900709 | 000 |
| 07613353056681 | K900709 | 000 |
| 07613353056674 | K900709 | 000 |
| 07613353048655 | K900709 | 000 |
| 07613353048648 | K900709 | 000 |
| 07613353002732 | K900709 | 000 |
| 07613353002725 | K900709 | 000 |
| 07613353002718 | K900709 | 000 |
| 07613353002701 | K900709 | 000 |
| 07613353002695 | K900709 | 000 |
| 07613353001773 | K900709 | 000 |
| 07613353077341 | K900709 | 000 |
| 07613353077358 | K900709 | 000 |
| 07613353172305 | K900709 | 000 |
| 07613353172299 | K900709 | 000 |
| 07613353172282 | K900709 | 000 |
| 07613353172275 | K900709 | 000 |
| 07613353167806 | K900709 | 000 |
| 07613353167790 | K900709 | 000 |
| 07613353167783 | K900709 | 000 |
| 07613353167776 | K900709 | 000 |
| 07613353167769 | K900709 | 000 |
| 07613353166052 | K900709 | 000 |
| 07613353115517 | K900709 | 000 |
| 07613353115500 | K900709 | 000 |
| 07613353192709 | K900709 | 000 |