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 |