The following data is part of a premarket notification filed by Airos Medical, Inc. with the FDA for Airos 6 Sequential Compression Device.
| Device ID | K172770 |
| 510k Number | K172770 |
| Device Name: | AIROS 6 Sequential Compression Device |
| Classification | Sleeve, Limb, Compressible |
| Applicant | AIROS Medical, Inc. 2501 Monroe Blvd, Suite 1200 Audubon, PA 19403 |
| Contact | Darren Behuniak |
| Correspondent | Darren Behuniak AIROS Medical, Inc. 2501 Monroe Blvd, Suite 1200 Audubon, PA 19403 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-14 |
| Decision Date | 2018-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10855682007154 | K172770 | 000 |
| 10855682007048 | K172770 | 000 |
| 10855682007055 | K172770 | 000 |
| 10855682007062 | K172770 | 000 |
| 10855682007079 | K172770 | 000 |
| 10855682007086 | K172770 | 000 |
| 10855682007093 | K172770 | 000 |
| 10855682007109 | K172770 | 000 |
| 10855682007116 | K172770 | 000 |
| 10855682007123 | K172770 | 000 |
| 10855682007130 | K172770 | 000 |
| 10855682007147 | K172770 | 000 |
| 00855682007010 | K172770 | 000 |