The following data is part of a premarket notification filed by Sun Scientific Inc with the FDA for Aerodvx System.
| Device ID | K183349 |
| 510k Number | K183349 |
| Device Name: | AeroDVx System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Sun Scientific Inc 145 Palisade Street Dobbs Ferry, NY 10522 |
| Contact | Allan Alward |
| Correspondent | Allan Alward Sun Scientific Inc 145 Palisade Street Dobbs Ferry, NY 10522 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856525007617 | K183349 | 000 |
| 00856525007105 | K183349 | 000 |
| 00856525007358 | K183349 | 000 |
| 00856525007341 | K183349 | 000 |
| 00856525007334 | K183349 | 000 |
| 00856525007822 | K183349 | 000 |
| 00856525007815 | K183349 | 000 |
| 00856525007808 | K183349 | 000 |
| 00856525007792 | K183349 | 000 |
| 00856525007785 | K183349 | 000 |
| 00856525007778 | K183349 | 000 |
| 00856525007761 | K183349 | 000 |
| 00856525007754 | K183349 | 000 |
| 00856525007853 | K183349 | 000 |
| 00856525007846 | K183349 | 000 |
| 00856525007112 | K183349 | 000 |
| 00856525007129 | K183349 | 000 |
| 00856525007631 | K183349 | 000 |
| 00856525007600 | K183349 | 000 |
| 00856525007594 | K183349 | 000 |
| 00856525007723 | K183349 | 000 |
| 00856525007709 | K183349 | 000 |
| 00856525007693 | K183349 | 000 |
| 00856525007686 | K183349 | 000 |
| 00856525007679 | K183349 | 000 |
| 00856525007662 | K183349 | 000 |
| 00856525007655 | K183349 | 000 |
| 00856525007648 | K183349 | 000 |
| 00856525007624 | K183349 | 000 |
| 00856525007587 | K183349 | 000 |
| 00856525007570 | K183349 | 000 |
| 00856525007716 | K183349 | 000 |
| 00856525007839 | K183349 | 000 |