The following data is part of a premarket notification filed by Airos Medical, Inc. with the FDA for Airos 8 Sequential Compression Device.
| Device ID | K193068 |
| 510k Number | K193068 |
| Device Name: | AIROS 8 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-04 |
| Decision Date | 2019-12-04 |